Author: Michelle Dryden

Cash-strapped Indonesians turn to online Sunday market

Post author By Michelle Dryden
Post date December 11, 2020
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A traditional Sunday market featuring Jakarta’s traditional arts and crafts moved online to help people who lost income and jobs during pandemic. (Dec. 11)

JAKARTA, Indonesia (AP) — Rani Nurwitawati never thought she would lose her job at an Indonesian market research company where she worked for 17 years.

The reality hit months after the COVID-19 pandemic.

“The impact is quite big for me,” the 41-year-old said. “My brother lost his job, my sister got a 25% pay cut. And finally, I also lost my job.”

Armed with the knowledge from her former employer that the food and beverage business will survive during the economic downturn, Nurwitawati decided to start selling food from her own kitchen.

She found an ally in Omah Wulangreh, an art and cultural community in South Jakarta that began an online version of the Pahingan Sunday market in August, only days after Nurwitawati lost her job.

The community used to host the Sunday market at its location, but it only accommodated limited tenants. As the pandemic tore through Indonesia, leaving many without income, the artists moved the market online, providing space for sellers to register online while buyers are required to preorder.

Sellers must follow some rules, including offering local artisan products and use minimum plastic packaging.

Aside from providing income for her daily living, Nurwitawati said that the Sunday market is giving her more experience in operating a new business.

“I have learned about networking, got new knowledge, and more people know my products,” she said. “When I joined for the first time, I was really sad because there was only one buyer, after that it increased to more than 10. It was not bad, from less than one 100,000 rupiah ($7) to hundreds of thousands rupiah.”

She prepares baked spaghetti and mango sticky rice.

Parahita Satiti, 37, also joined the Sunday market. She has always dreamed of running a business related to traditional fashion products. She hopes to get extra income after her office cut her monthly allowance by half during the pandemic. She sells traditional Javanese kebaya — women’s upper long-sleeved clothes — and camisole — a loose-fitting sleeveless undergarment — made of Javanese batik cloth.

“This is a new business, but seeing the enthusiasm and orders from the Pahingan Sunday market, I think it will be a promising business for me,” Satiti said.

Reny Ajeng, one of the organizers of the Sunday market, said it’s held once every 35 days, following the five-day Javanese calendar.

Strict social restrictions imposed in Indonesia during the pandemic have stopped the physical market as well as other cultural and art activities at Omah Wulangreh. The online version came to life when Reny and her six friends decided to launch it in early August.

There were 46 tenants who joined the third online event last month. Buyers had one week to preorder item, such as traditional snacks, batik clothes, or coffee. During one week, there were almost 500 items sold, worth about 25 million rupiah ($1,770).

“To be honest, we are really happy,” Reny said. “Our first mission was to make an online Sunday market since we can do nothing offline during the pandemic. But it turns out, enthusiasm is high, so many sellers are having high hopes.”

___ “One Good Thing” is a series that highlights individuals whose actions provide glimmers of joy in hard times — stories of people who find a way to make a difference, no matter how small. Read the collection of stories at https://apnews.com/hub/one-good-thing

— Associated Press

For Edit

In Arizona, Trump’s false claims have torn open a GOP rift

Post author By Michelle Dryden
Post date December 11, 2020
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FILE – In this Oct. 19, 2020 file photo, President Donald Trump, left, pauses with Arizona Gov. Doug Ducey during a campaign rally in Tucson, Ariz. Ducey spent much of Trump’s presidency trying not to provoke confrontation with the president or his fervent defenders. When state law required Ducey to certify Arizona’s presidential election results and sign off on Trump’s defeat last week, four years of loyalty wasn’t enough to protect him from the president. (AP Photo/Ross D. Franklin, File)

PHOENIX (AP) — Arizona Gov. Doug Ducey spent much of Donald Trump’s presidency trying not to provoke confrontation with the president or his fervent defenders. He almost made it through.

But when state law required Ducey to certify Arizona’s presidential election results and sign off on Trump’s defeat last week, four years of loyalty wasn’t enough to protect him from the president. “Republicans will long remember!,” Trump tweeted in anger at the governor.

Since then, the episode has spiraled into a public and politically damaging dispute between Ducey and influential Trump loyalists in his own party. Those who believe Trump’s unproven claims of fraud and support his effort to undermine the will of voters say Ducey betrayed his party. His defenders have dismissed the critics as “nuts.”

The rift may be a preview the lasting political impact of Trump’s campaign to subvert the election results. As the president’s baseless claims gain traction with many GOP voters, Republican officeholders will be asked to take sides — back Trump or acknowledge the reality that Biden won an election with no proven claims of widespread fraud. Their choices could have long-term consequences for their own political futures.

“He’s in a no-win situation on many fronts,” said Doug Cole, a Republican political consultant and adviser to past governors, of Ducey, who is widely believed to be eying a bid for Senate or even the White House.

Ducey is one of two GOP governors who have faced Trump backlash after certifying Biden’s win in their states. GOP Gov. Brian Kemp of Georgia also signed off on Trump’s loss and refused to endorse Trump’s attempts overturn the results. Trump has lashed out in response.

But many other GOP governors and lawmakers have dodged questions about whether Biden is the winner, with some suggesting they’re waiting until Jan. 6, when Congress is due to approve the Electoral College vote.

It didn’t take long for Ducey to find himself at the center of a schism. Trump called Ducey while the governor was in the process of signing the certification of Arizona’s election results in front of television cameras. The governor quickly pulled his phone from his suit jacket as it played the presidential anthem, “Hail to the Chief,” silenced it and set it on the table. He later returned Trump’s call but declined to tell reporters what they discussed.

Hours after, Trump began his tirade against Ducey on Twitter, which seemed to open the floodgates for his staunchest supporters.

Kelli Ward, the firebrand chair of the Arizona Republican Party said she was “disgusted” with Ducey and addressed him on Twitter with an acronym meaning “shut the hell up.”

Ducey clapped back in a news conference: “The feeling’s mutual…Practice what you preach.”

Ducey’s advisers opened up on the governor’s critics on Twitter. His chief of staff, Daniel Scarpinato, called Rep. Andy Biggs, an Arizona Republican who leads the conservative Freedom Caucus, “nuts” and “a permanent resident of Crazytown.” Ducey’s former chief of staff, Kirk Adams, asked a state lawmaker who’s pushing to overturn the election results, “Have you considered counseling? It can help.”

On Wednesday, Biggs published an online op-ed Wednesday declaring, “Gov. Ducey Has Harmed the Republican Party’s Cause.”

Barrett Marson, a Republican political consultant, doesn’t think Ducey’s problem with the conservative GOP base will last.

“Donald Trump’s tweets come and go,” said Marson, who previously worked for a Ducey-aligned political action committee to elect Republican legislators. “The governor has been a supporter of the president’s agenda, his economic policies and so forth. This one hiccup won’t fray that relationship going forward.”

After avoiding Trump during the 2016 campaign, Ducey came to embrace him, even when Trump’s policies were problematic for Ducey’s allies in the Arizona business community. When Trump would muse about closing the southern border, a potentially devastating move in a state with strong economic ties with Mexico, Ducey backed him.

And as Arizona became a pivotal swing state in the 2020 contest and Trump made constant visits, Ducey was always by his side with effusive praise. The president returned the favor by touting Ducey’s handling of the coronavirus, which he called a model for other states.

But he also warned just days before the election that his support would only go so far.

“We’re doing well Doug? We’re doing good?” Trump said at a rally in conservative Bullhead City. “I’m gonna be so angry at you Doug if I don’t get there.”

Since Biden’s narrow victory in Arizona, Ducey has never lent credence to the conspiracy theories lobbed by the president, his attorneys and allies alleging fraud. Still, he waited three weeks before acknowledge Biden’s victory, which he did only when pressed repeatedly by an interviewer. He’s challenged those questioning the election results to present their evidence in court.

Ducey’s estrangement from portions of his party base began earlier this year when he ordered the closure of businesses to preserve hospital capacity and protective gear as the spread of the coronavirus intensified. But he maintained the president’s strong backing until now.

Barred by term limits from running again for governor, Ducey faces a crossroads in his political future. Observers in Arizona have long speculated on what he wants to do next. Trump’s loss deprives him of the chance to seek an administration job in Washington.

He could run for the U.S. Senate against newly elected Democrat Mark Kelly but would almost certainly face a primary challenge from the right, especially if his relationship with Trump remains strained.

“Short term, we know that when the president sours on anyone … there’s a group of Republicans out there that, wherever the president goes, they will go,” said Mike Noble, a Phoenix pollster and former GOP political consultant. “The question is going to be whether or not those folks stick to that.”

— Associated Press

International & World

New report says part of South Sudan is in “likely famine“

Post author By Michelle Dryden
Post date December 11, 2020
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Malnourished five-month old Tiere Pascol, whose mother can’t afford food and has trouble breastfeeding, lies in his mother’s arms at a feeding center in Al Sabah Children’s Hospital in the capital Juba, South Sudan Thursday, Dec. 3, 2020. One county in South Sudan is likely in famine and tens of thousands of people in five other counties are on the brink of starvation, according to a new report released Friday, Dec. 11, 2020 by international food security experts. (AP Photo/Sam Mednick)

JUBA, South Sudan (AP) — One county in South Sudan is likely in famine and tens of thousands of people in five other counties are on the brink of starvation, according to a new report by international food security experts.

Nowhere in the world has been in famine since one was declared nearly four years ago in South Sudan’s Unity state as civil war raged. Now western Pibor county is feared to have reached that crisis level, the result of massive flooding and deadly violence that has prevented access to aid.

The new report stops short of declaring famine, which would kick aid efforts into higher gear, because of insufficient data. But based on available information, famine is thought to be occurring, according to the Famine Review Committee report released by the Integrated Food Security Phase Classification. That means at least 20% of households are facing extreme food gaps and at least 30% of children are acutely malnourished.

“Considering all the evidence available, famine is most likely ongoing, and we expect a high rate of death in that area,” said Chris Newton, a former U.N. World Food Program staffer with years of experience in South Sudan.

“The condition is catastrophic, and the humanitarian community and the government will have to scale up our assistance,” said Meshack Malo, country representative for the U.N.’s Food and Agriculture Organization.

The report says catastrophe conditions are also occurring in five counties across South Sudan in Jonglei, Warrap and Northern Bahr el Ghazal states, where 5% to 10% of the population is facing starvation.

South Sudan’s government did not endorse the report. In a statement earlier this week, it urged caution in claiming famine conditions and said any famine occurring on the government and aid community’s watch is a “testament of failure by both parties.”

Aid workers worry that already challenging humanitarian access will become more difficult in these hungry areas. The report says there is less than a 50% chance that planned food assistance will be delivered to the affected areas in the months ahead.

South Sudan has been struggling to recover from five years of war that killed almost 400,000 people, according to a past study by the London School of Hygiene & Tropical Medicine. A coalition government formed this year between President Salva Kiir and opposition leader Riek Machar is implementing a peace deal behind schedule, while deadly violence continues in parts of the country.

The violence is the worst in Jonglei state and the Greater Pibor Administrative Area, where hunger is the most severe.

“This famine is a result of the broader impact of violence on human lives,” said Edmund Yakani, executive director of the Community Empowerment for Progress Organization, a civil society group. He blamed “politicians who tend to use violence as an option for controlling power.”

Between January and May there was a 220% increase in incidents of intercommunal violence compared with the same period two years ago, the U.N. has said, with the government and opposition often providing arms.

A U.N. panel of experts has said the fighting prevented people from cultivating, blocked supply routes and burned down markets while humanitarian warehouses were looted and several humanitarian workers were killed.

Acting army spokesman Santo Domic Chol said the army has never denied civilians access to aid.

The problems have been compounded by the worst local flooding in decades, which has displaced more than 1 million people since July. Most of them are in Jonglei and the Greater Pibor Administrative Area, according to the U.N.

On a visit to the community of Old Fangak in Jonglei last month, displaced residents said the floods had wiped out their crops and cattle.

“It is difficult to get food unless we get it from the humanitarian organizations,” said a dispirited Regina Nyakul. Since her home was destroyed by the floods, the mother of nine shelters in a school with her children.

Sometimes they fall ill due to a lack of food, she said.

At the market, trader Gatluak Billiew said the floods had spoiled food commodities and made it difficult to restock.

“We are very worried about the upcoming dry season that will lead to more violence” bringing yet another crisis, said Jose Mas Campos, head of mission for Doctors Without Borders in South Sudan.

But the hunger is a countrywide problem. A recent World Bank phone survey of more than 1,200 people in South Sudan found that nearly 73% reported going without eating for a whole day due to a lack of money. A drop in oil prices, the country’s main source of revenue, along with inflation and impacts of the COVID-19 pandemic have worsened an economic crisis.

At the Al-Sabah Children’s hospital in the capital, Juba, doctors say they have seen an increase in children dying from malnutrition.

Eighty-five died between January and December, compared with 62 over the same period last year, even though the hospital has received less patients, said James Mawien Tong, head doctor at the hospital’s feeding center.

Many children die within 24 hours of arrival because their parents wait too long to bring them, he said. The families are largely from Juba and the surrounding area.

Seated on the floor, Angelina Ater soothed her sobbing 2-year-old daughter as she was fed through a tube in her nose.

The 20-year-old said that since August, the economic crisis has forced her family to eat just once a day because they can’t afford food.

“The situation is not good,” she said. “We really need help.”

— Associated Press

International & World

Charges in Beirut port blast stir controversy in Lebanon

Post author By Michelle Dryden
Post date December 11, 2020
No Comments on Charges in Beirut port blast stir controversy in Lebanon

FILE – In this Jan. 21, 2020 file photo, outgoing Lebanese Prime Minister Hassan Diab, speaks during a press conference after his government was announced, at the Presidential Palace in Baabda, east of Beirut, Lebanon. On Thursday, Dec. 10, 2020, the Lebanese prosecutor probing this summer’s port explosion in Beirut filed charges against Diab, and three former ministers, Lebanon’s official news agency said. All four were charged with negligence leading to deaths over the Aug. 4 explosion at Beirut port, which killed more than 200 people and injured thousands. (AP Photo/Bilal Hussein, File)

BEIRUT (AP) — Lebanon’s militant Hezbollah group on Friday criticized charges filed by a prosecutor against the caretaker prime minister and three former ministers over the massive explosion in Beirut’s port, describing it as “political targeting.”

The group called on investigating judge Fadi Sawwan to reconsider his decision, saying it lacked legal and constitutional basis and that the four were being selectively charged.

Similar criticism was voiced by Lebanon’s grand mufti, the top cleric for Sunni Muslims, and Prime Minister-designate Saad Hariri, who said the charges against caretaker Premier Hassan Diab targeted the prime ministry as a position and were a violation of the constitution. The prime minister in Lebanon must be a Sunni Muslim, according to the country’s sectarian-based power-sharing system.

It was not clear what impact the criticism could have on Sawwan. In a surprise move, he filed charges against Diab and three former ministers on Thursday, accusing them of negligence that led to the death of hundreds of people.

The four are the most senior officials to be charged in the investigation and are set to be questioned as defendants next week by Sawwan.

Diab, who is supported by Hezbollah and its political allies, resigned in the wake of the Aug. 4 explosion and remains in his post in a caretaker capacity, as Lebanese officials have failed to agree on a new Cabinet.

The Aug. 4 explosion was caused by the ignition of a large stockpile of explosive material that had been stored at the port for six years, with the knowledge of top security officials and politicians who did nothing about it. It killed more than 200 people and wounded thousands, devastating large parts of the capital of Beirut.

Thursday’s decision to charge senior officials — including one in office — was significant in Lebanon, where a culture of impunity has prevailed for decades, including among the entrenched political elites.

According to Lebanon’s constitution, a separate council made up of judges and politicians is entrusted with trying ministers and presidents for crimes of high treason, dereliction of duties, and breach of the constitution.

The move by Sawwan to exercise his jurisdiction to accuse government officials came after he sent a letter and documents to parliament last month, informing lawmakers of serious suspicions relating to government officials and asking them to investigate. The lawmakers responded by saying that the material they received did not point to any professional wrongdoing.

Lawyer Youssef Lahoud, who represents the Bar Association in the investigation, said the parliament’s response does not prevent Sawan from exercising his right to charge government officials in the port explosion. The explosion is not viewed as a political crime, which would require the role of parliament, Lahoud said.

The three former ministers charged along with Diab are allies of Hezbollah. They are former Finance Minister Ali Hassan Khalil, as well as Ghazi Zeiter and Youssef Fenianos, both former ministers of public works.

“We are keen that all decisions taken by the investigating judge stay clear of politics and intent; be constitutional and not subject to interpretation or judgement; and that the indictment be based on legal and reasonable basis, which is what we did not find in the latest measures,” Hezbollah said in a statement.

“Therefore we absolutely reject the absence of unified criteria which led to what we consider political targeting affecting some people and ignoring others unfairly,” it added.

A statement from Diab’s office on Thursday accused Sawwan of violating the constitution and bypassing parliament. Although a political opponent, Hariri visited Diab on Friday in a gesture of solidarity.

Lebanon’s grand mufti and top cleric for Sunni Muslims, Sheikh Abdel-Latif Derian, also said the charges targeting the prime minister’s position is political and, unacceptable and a violation of the constitution.

Zeiter, the former minister of public works and currently a lawmaker, said in a press conference on Friday that the judge deviated from constitutional rules and abused power.

The judge committed a “catastrophe” on the judicial scale, Zeiter said, adding that he and the others charged would not be silenced by “any fake accusations.”

___

Associated Press writer Sarah El Deeb contributed reporting.

— Associated Press

Healthcare

Bristol Myers Squibb receives positive CHMP opinion for Inrebic® (fedratinib) for adult patients with newly diagnosed and previously treated myelofibrosis

If approved, Inrebic will become the first new therapy for myelofibrosis in Europe in nearly a decade

Inrebic, if approved, will also be the first once-daily, oral therapy to demonstrate clinically meaningful spleen and symptom response for patients with myelofibrosis where treatment with ruxolitinib has failed or who are JAK inhibitor naïve

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #BMS—Bristol Myers Squibb (NYSE: BMY) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Inrebic^® (fedratinib) for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis, who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, Inrebic will be the first, once-daily oral therapy to significantly reduce spleen volume and symptom burden for patients with myelofibrosis where treatment with ruxolitinib has failed or who are JAK inhibitor naïve.

The CHMP adopted a positive opinion based on results from the JAKARTA and JAKARTA2 studies. The pivotal JAKARTA study evaluated the efficacy of once-daily oral doses of Inrebic compared with placebo in 289 patients with intermediate-2 or high-risk primary or secondary myelofibrosis with splenomegaly.¹ The JAKARTA2 study evaluated the efficacy of once-daily oral doses of Inrebic in 97 patients with intermediate or high-risk primary or secondary myelofibrosis with splenomegaly previously treated with ruxolitinib.²

“For nearly a decade, patients with myelofibrosis who have progressed on ruxolitinib have had no treatment options for this rare bone marrow disorder, characterized by debilitating symptoms and an enlarged spleen,” said Diane McDowell, M.D., vice president, Hematology Global Medical Affairs, Bristol Myers Squibb. “The positive CHMP opinion for Inrebic reinforces our commitment to improving on standards of care for patients living with hard-to-treat blood diseases and we look forward to the European Commission’s decision.”

The EC is expected to deliver its final decision within 67 days of receipt of the CHMP opinion. The decision will be applicable to all EU member states and Iceland, Norway and Liechtenstein.

Inrebic is approved in the United States for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.¹In Canada, Inrebic is approved for the treatment of splenomegaly and/or disease related symptoms in adult patients with intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, including patients who have been previously exposed to ruxolitinib.³

In the clinical development program of Inrebic, which included 608 patients, serious and fatal cases of encephalopathy, including Wernicke’s, occurred in Inrebic-treated patients. Serious cases were reported in 1.3% (8/608) of patients treated with Inrebic in clinical trials and 0.16% (1/608) of cases were fatal.

About JAKARTA and JAKARTA2

The Inrebic development program consisted of multiple studies (including JAKARTA and JAKARTA2) in 608 patients who received more than one dose (ranging from 30 mg to 800 mg), of whom 459 had myelofibrosis, including 97 previously treated with ruxolitinib.³ JAKARTA was a pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy of once-daily oral doses of Inrebic compared with placebo in patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with splenomegaly and a platelet count of ≥50 x 10⁹/L who were previously untreated with a JAK inhibitor. The study included 289 patients randomized to receive either Inrebic 500 mg (n=97) or 400 mg (n=96) or placebo (n=96)¹ across 94 sites in 24 countries.¹ JAKARTA2 was a Phase 2, open-label, single arm study of Inrebic in myelofibrosis patients previously treated with ruxolitinib with a diagnosis of intermediate-1 with symptoms, intermediate-2 or high-risk myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis with splenomegaly and platelet count ≥50 x 10⁹/L. The study included 97 patients who started Inrebic at 400 mg once daily across 10 countries.²

The primary endpoint of JAKARTA and JAKARTA2 was spleen response rate, defined as the proportion of patients achieving greater than or equal to a 35% reduction from baseline in spleen volume at the end of cycle 6 as measured by magnetic resonance imaging (MRI) or computerized tomography (CT) with a follow-up scan 4 weeks later. Secondary endpoints of the studies included symptom response rate, defined as the proportion of patients with a 50% or greater reduction in Total Symptom Score when assessed from baseline to the end of cycle 6 as measured by the modified Myelofibrosis Symptoms Assessment Form (MFSAF) v2.0 diary2 (night sweats, itching, abdominal discomfort, early satiety, pain under ribs on left side, bone or muscle pain).^1,2

About Myelofibrosis

Myelofibrosis is a serious and rare bone marrow disorder that disrupts the body’s normal production of blood cells. Bone marrow is gradually replaced with fibrous scar tissue, which limits the ability of the bone marrow to make blood cells. The disorder can lead to anemia, weakness, fatigue and enlargement of the spleen and liver, among other symptoms.⁴ Myelofibrosis is classified as a myeloproliferative neoplasm, a group of rare blood cancers that are derived from blood-forming stem cells.⁵ In the EU, approximately 1 of every 100,000 people will be diagnosed with myelofibrosis each year.⁶ Both men and women are affected, and while the disease can affect people of all ages, the median age at diagnosis ranges from 60 to 67 years.^7,8

About Inrebic

Inrebic^® (fedratinib) is an oral kinase inhibitor with activity against wild type and mutationally activated Janus Associated Kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3). Inrebic is a JAK2-selective inhibitor with higher potency for JAK2 over family members JAK1, JAK3 and TYK2. Abnormal activation of JAK2 is associated with myeloproliferative neoplasms, including myelofibrosis and polycythemia vera. In cell models expressing mutationally active JAK2 or FLT3, Inrebic reduced phosphorylation of signal transducer and activator of transcription (STAT3/5) proteins, inhibited cell proliferation, and induced apoptotic cell death. In mouse models of JAK2V617F-driven myeloproliferative disease, Inrebic blocked phosphorylation of STAT3/5, increased survival and improved disease-associated symptoms, including reduction of white blood cells, hematocrit, splenomegaly and fibrosis.¹

U.S. INDICATION

INREBIC^® (fedratinib) is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).

U.S. IMPORTANT SAFETY INFORMATION

WARNING: ENCEPHALOPATHY INCLUDING WERNICKE’S

Serious and fatal encephalopathy, including Wernicke’s, has occurred in patients treated with INREBIC. Wernicke’s encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC, periodically during treatment, and as clinically indicated. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize.

WARNINGS AND PRECAUTIONS

Encephalopathy, including Wernicke’s: Serious and fatal encephalopathy, including Wernicke’s encephalopathy, has occurred in INREBIC-treated patients. Serious cases were reported in 1.3% (8/608) of patients treated with INREBIC in clinical trials and 0.16% (1/608) of cases were fatal.

Wernicke’s encephalopathy is a neurologic emergency resulting from thiamine (Vitamin B1) deficiency. Signs and symptoms of Wernicke’s encephalopathy may include ataxia, mental status changes, and ophthalmoplegia (e.g., nystagmus, diplopia). Any change in mental status, confusion, or memory impairment should raise concern for potential encephalopathy, including Wernicke’s, and prompt a full evaluation including a neurologic examination, assessment of thiamine levels, and imaging. Assess thiamine levels in all patients prior to starting INREBIC, periodically during treatment, and as clinically indicated. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize.

Anemia: New or worsening Grade 3 anemia occurred in 34% of INREBIC-treated patients. The median time to onset of the first Grade 3 anemia was approximately 2 months, with 75% of cases occurring within 3 months. Mean hemoglobin levels reached nadir after 12 to 16 weeks with partial recovery and stabilization after 16 weeks. Red blood cell transfusions were received by 51% of INREBIC-treated patients and permanent discontinuation of INREBIC occurred due to anemia in 1% of patients. Consider dose reduction for patients who become red blood cell transfusion dependent.

Thrombocytopenia: New or worsening Grade ≥3 thrombocytopenia during the randomized treatment period occurred in 12% of INREBIC-treated patients. The median time to onset of the first Grade 3 thrombocytopenia was approximately 1 month; with 75% of cases occurring within 4 months. Platelet transfusions were received by 3.1% of INREBIC-treated patients. Permanent discontinuation of treatment due to thrombocytopenia and bleeding that required clinical intervention both occurred in 2.1% of INREBIC-treated patients. Obtain a complete blood count (CBC) at baseline, periodically during treatment, and as clinically indicated. For Grade 3 thrombocytopenia with active bleeding or Grade 4 thrombocytopenia, interrupt INREBIC until resolved to less than or equal to Grade 2 or baseline. Restart dose at 100 mg daily below the last given dose and monitor platelets as clinically indicated.

Gastrointestinal Toxicity: Gastrointestinal toxicities are the most frequent adverse reactions in INREBIC-treated patients. During the randomized treatment period, diarrhea occurred in 66% of patients, nausea in 62% of patients, and vomiting in 39% of patients. Grade 3 diarrhea 5% and vomiting 3.1% occurred. The median time to onset of any grade nausea, vomiting, and diarrhea was 1 day, with 75% of cases occurring within 2 weeks of treatment. Consider providing appropriate prophylactic anti-emetic therapy (e.g., 5-HT3 receptor antagonists) during INREBIC treatment. Treat diarrhea with anti-diarrheal medications promptly at the first onset of symptoms. Grade 3 or higher nausea, vomiting, or diarrhea not responsive to supportive measures within 48 hours, interrupt INREBIC until resolved to Grade 1 or less or baseline. Restart dose at 100 mg daily below the last given dose. Monitor thiamine levels and replete as needed.

Hepatic Toxicity: Elevations of ALT and AST (all grades) during the randomized treatment period occurred in 43% and 40%, respectively, with Grade 3 or 4 in 1% and 0%, respectively, of INREBIC-treated patients. The median time to onset of any grade transaminase elevation was approximately 1 month, with 75% of cases occurring within 3 months. Monitor hepatic function at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher ALT and/or AST elevations (greater than 5 × ULN), interrupt INREBIC dose until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose. If re-occurrence of a Grade 3 or higher elevation of ALT/AST, discontinue treatment with INREBIC.

Amylase and Lipase Elevation: Grade 3 or higher amylase 2% and/or lipase 10% elevations developed in INREBIC-treated patients. The median time to onset of any grade amylase or lipase elevation was 15 days, with 75% of cases occurring within 1 month of starting treatment. One patient developed pancreatitis in the fedratinib clinical development program (n=608) and pancreatitis resolved with treatment discontinuation. Monitor amylase and lipase at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher amylase and/or lipase elevations, interrupt INREBIC until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose.

ADVERSE REACTIONS:

The most common adverse reactions for INREBIC treated vs. placebo were diarrhea (66% vs. 16%), nausea (62% vs. 15%), anemia (40% vs. 14%), and vomiting (39% vs. 5%). Dosage interruptions due to an adverse reaction during the randomized treatment period occurred in 21% of patients who received INREBIC. Adverse reactions requiring dosage interruption in >3% of patients who received INREBIC included diarrhea and nausea. Dosage reductions due to an adverse reaction during the randomized treatment period occurred in 19% of patients who received INREBIC. Adverse reactions requiring dosage reduction in >2% of patients who received INREBIC included anemia (6%), diarrhea (3%), vomiting (3%), and thrombocytopenia (2%).

DRUG INTERACTIONS:

Coadministration of INREBIC with a strong CYP3A4 inhibitor increases fedratinib exposure. Increased exposure may increase the risk of adverse reactions. Consider alternative therapies that do not strongly inhibit CYP3A4 activity. Alternatively, reduce the dose of INREBIC when administering with a strong CYP3A4 inhibitor. Avoid INREBIC with strong and moderate CYP3A4 inducers. Avoid INREBIC with dual CYP3A4 and CYP2C19 inhibitor. Coadministration of INREBIC with drugs that are CYP3A4 substrates, CYP2C19 substrates, or CYP2D6 substrates increases the concentrations of these drugs, which may increase the risk of adverse reactions of these drugs. Monitor for adverse reactions and adjust the dose of drugs that are CYP3A4, CYP2C19, or CYP2D6 substrates as necessary when coadministered with INREBIC.

PREGNANCY/LACTATION: Consider the benefits and risks of INREBIC for the mother and possible risks to the fetus when prescribing INREBIC to a pregnant woman. Due to the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with INREBIC, and for at least 1 month after the last dose.

RENAL IMPAIRMENT: Reduce INREBIC dose when administered to patients with severe renal impairment. No modification of the starting dose is recommended for patients with mild to moderate renal impairment. Due to potential increase of exposure, patients with preexisting moderate renal impairment require more intensive safety monitoring, and if necessary, dose modifications based on adverse reactions.

HEPATIC IMPAIRMENT: Avoid use of INREBIC in patients with severe hepatic impairment.

Please see full Prescribing Information, including Boxed WARNING.

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision—transforming people’s lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the CHMP opinion is not binding on the EC, that Inrebic^® (fedratinib) may not receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all and, if approved, whether such product candidate for such indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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References:

INREBIC U.S. Prescribing Information. Accessed November 2020.
Clinical Trials.gov. Phase II, Open Label, Single Arm Study of SAR302503 In Myelofibrosis Patients Previously Treated With Ruxolitinib (JAKARTA2). Available at https://clinicaltrials.gov/ct2/show/NCT01523171. Accessed November 2020.
INREBIC Canada Product Monograph. Accessed November 2020.
Mayo Clinic. Myelofibrosis. Available at: https://www.mayoclinic.org/diseases-conditions/myelofibrosis/symptomscauses/syc-20355057. Accessed November 2020.
Leukemia & Lymphoma Society. Myelofibrosis. Available at: https://www.lls.org/myeloproliferativeneoplasms/myelofibrosis. Accessed November 2020.
Moulard O, et al. Epidemiology of myelofibrosis, essential thrombocythemia, and polycythemia vera in the European Union. European Journal of Haematology. 2013;92:289/297.
Mesa RA, Silverstein MN, Jacobsen SJ, et al. Population-based incidence and survival figures in essential thrombocythemia and agnogenic myeloid metaplasia: an Olmsted County Study, 1976-1995. Am J Hematol. 1999;61(1):10-15.
Abdel-Wahab O and Levine R. Primary myelofibrosis: Updates on Definition, Pathogenesis and Treatment. Annual Review of Medicine. 2009;60:233-245.
Mesa R, Niblack J, Wadleigh M, et al. The burden of fatigue and quality of life in myeloproliferative disorders (MPDs). Cancer. 2007;109:68-76.

Contacts

Bristol Myers Squibb

Media Inquiries:
media@bms.com

Investors:
Tim Power

609-252-7509

timothy.power@bms.com

Nina Goworek

908-673-9711

Nina.Goworek@bms.com

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