In a boon for buyer Bristol-Myers, Celgene's JAK med Inrebic scores FDA nod

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Celgene's JAK inhibitor Inrebic scored a nod of approval from the FDA. (Celgene)

Bristol-Myers Squibb’s $74 billion Celgene takeover has been a bit of a roller coaster, with some Revlimid patent wins on the upside and, on the down, a Federal Trade Commission-forced sale of blockbuster Otezla. But the FDA just handed the merger partners another win.

A once-left-for-dead centerpiece of that deal is now ready to launch after the FDA approved Celgene’s JAK inhibitor Inrebic (fedratinib) Friday as a first-line or follow-up treatment for myelofibrosis. The once-daily oral drug is the first new treatment in nearly a decade approved to treat the disease, Celgene said.

It’s not all great news for Inrebic, though: The drug will come with a black box warning for serious and fatal encephalopathy, including Wernicke’s. The drugmaker said serious encephalopathy was reported in 1.3% of trial patients treated with Inrebic, and one of those patients died.

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Myelofibrosis is a serious and rare bone marrow disorder that disrupts the body’s normal production of blood cells and affects between 16,000 and 18,500 U.S. patients, Celgene said. Inrebic is OK'd for adults with intermediate- or high-risk cases of primary or secondary disease.

RELATED: 2 months after BMS megamerger, Celgene's JAK inhibitor to get priority review

The story of Inrebic’s rising from the dead is a major success for Celgene, which picked up the drug as a part of a $1.1 billion acquisition of Impact Biomedicines in early 2018. Before that, Inrebic had passed through multiple hands after it was developed by TargeGen and then acquired by Sanofi. The French drugmaker ultimately called off its clinical trials in 2013 after the FDA placed a hold on the drug.

Inrebic was one of the “big 5” candidates Bristol was set to pick up as part of its Celgene acquisition deal struck in January. Another serious contender, multiple sclerosis hopeful ozanimod, had its application picked up by the FDA in June, providing Bristol another arrow in its sling for the takeover haters.

RELATED: Among recent megamergers, only AbbVie-Allergan looks like a winner: analyst

All that good news has been tempered by skepticism from some analysts, who've targeted the companies’ mandatory divestment of psoriasis drug Otezla, which raked in $1.6 billion in sales in 2018.

SVB Leerink analyst Geoffrey Porges said BMS is still poised to be a top player in oncology, cardiovascular disease and hematology, but the loss of Otezla, coupled with patent expirations, will slow top-line growth and put considerable pressure on late-stage pipeline drugs from Celgene, including luspatercept to treat myelodysplastic syndromes.

RELATED: Red flag upgrade for Pfizer: FDA limits Xeljanz in colitis, slaps black box on label

Inrebic will join a new class of JAK inhibitors that's expected to get a lot more crowded in the coming months.

Two candidates, AbbVie’s upadacitinib and Gilead Sciences’ filgotinib, are approaching the market, with the former under FDA priority review. Evaluate Pharma analysts previously estimated upadacitinib could reach $2.18 billion in annual sales by 2024.

The leading JAK inhibitor on the market, Pfizer’s Xeljanz, turned in $613 million in second-quarter sales despite being hit with a new black box warning in July for an increased risk of blood clots and possibly death.

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