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

FDA Building
Celgene is developing fedratinib for the treatment of myelofibrosis, a rare disorder in which the bone marrow is replaced with scar tissue and cannot produce enough blood cells. (FDA)

Bristol-Myers Squibb splashed into 2019, announcing its $74 billion megamerger with Celgene. At the time, CEO Giovanni Caforio, M.D., expressed his excitement about the “doubling” of BMS’ pipeline and the momentum the deal would bring. Now, the FDA has granted Celgene’s JAK inhibitor, fedratinib, priority review, with a PDUFA date of Sept. 3.

Fedratinib is just one of several late-stage programs that BMS will pick up in the acquisition; the others include a CAR-T treatment for multiple myeloma, ozanimod to treat multiple sclerosis and luspatercept for beta thalassemia. The deal gives BMS the opportunity for six near-term product launches, Caforio said on a conference call with analysts after the announcement, as well as a wide-ranging early- and midstage pipeline.

Celgene is developing fedratinib for the treatment of myelofibrosis, a rare disorder in which the bone marrow is replaced with scar tissue and cannot produce enough blood cells. Fedratinib found its way to Celgene through a $1 billion acquisition unveiled a year earlier: The Big Biotech kicked off J.P. Morgan 2018 with its $1.1 billion buyout of Impact Biomedicines. The JAK2 inhibitor, a Sanofi castoff, has gone through many hands, having been developed at TargeGen before its acquisition by Sanofi, then on to Impact and Celgene before it settles at BMS. Sanofi halted the program after the FDA placed a clinical hold on it in 2013.

The NDA for fedratinib is based on a pair of trials testing the drug in patients with primary or secondary myelofibrosis—a randomized, placebo-controlled, phase 3 study and the single-arm, open-label, phase 2 trial in patients who had previously been treated with Jakafi (ruxolitinib), the only FDA-approved treatment for the disease. Celgene also wants to test fedratinib in combination with luspatercept, which is in development for beta thalassemia and myelodysplastic syndromes, in addition to myelofibrosis.

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Several players have been working on JAK inhibitors as a treatment for cancer, inflammatory disease and autoimmune disease. Novartis’ Jakafi is approved for myelofibrosis and the slow-growing blood cancer Polycythemia vera, while Pfizer’s Xeljanz (tofacitinib) and Eli Lilly’s Olumiant (baricitinib) are both approved for rheumatoid arthritis.

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However, there is still room for improvement in the arthritis space, as both Xeljanz and Olumiant are saddled with black-box safety warnings. Gilead and Galapagos’ phase 3 filgotinib could quickly catch up and overtake its competitors. In the meantime, some big names are trying to make JAK inhibitors work in other diseases: Genentech is working on a JAK1 inhibitor for the localized treatment of asthma and Janssen partnered with Theravance last February to develop a JAK inhibitor for inflammatory bowel disease.

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