Bristol Myers Squibb turns in priority review voucher for supplemental indication on an old Celgene drug
After turning around Celgene’s S1P modulator for a long-awaited approval in multiple sclerosis, Bristol Myers Squibb is now trading in an FDA wildcard to get a quick review in ulcerative colitis.
BMS has redeemed a priority review voucher for a speedy decision on its supplemental NDA for Zeposia, which hit the market this past June for MS. The FDA set a PDUFA date for May 30 — and if given the thumbs up, BMS says it would have the first oral sphingosine-1-phosphate (S1P) receptor modulator for UC.
The submission was based on results from the Phase III True North study, in which Zeposia met both primary endpoints in adults with moderately to severely active UC: the proportion of patients in clinical remission based at week 10 in the induction phase, and at week 52 for the maintenance phase. Zeposia’s effect was highly statistically significant (p-value < 0.0001) the company said in June, adding that the drug also met key secondary endpoints.
The overall safety profile was consistent with that of the already approved indication, BMS said in a statement.
UC is a chronic inflammatory bowel disease characterized by an abnormal, prolonged immune response that creates long-lasting inflammation and ulcers in the lining of the large intestine. Zeposia works in MS by reducing the capacity of lymphocytes to exit lymph nodes, thus reducing the number of circulating lymphocytes in peripheral blood. While the mechanism of action in UC is still unclear, BMS thinks it may involve the reduction of lymphocyte migration into the inflamed intestinal mucosa, or lining.
BMS snagged Zeposia when it bought out Celgene for $74 billion back in 2019. The drug, chemically known as ozanimod, had been sidelined after Celgene was flagged for lame conduct in filing a drug application. The FDA slapped Celgene with a refuse-to-file letter, concluding that the “nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a complete review.” BMS flipped the drug around for an OK in March, making it the third oral S1P modulator approved for MS.
The company held back on commercialization until June, due to the Covid-19 pandemic. Now time is of the essence, as they race for marketing approval in UC.
Priority review vouchers are, in some ways, like a regulatory “I owe you”: They allow companies to have one of their drugs fast-tracked under the FDA’s priority review system. The idea of using a voucher system was first proposed as a way to incentivize the development of drugs for neglected tropical diseases. The first version was incorporated in the Food and Drug Administration Amendments Act (FDAAA) of 2007. Since then, guidance has been issued covering more indications, and allowing companies to buy and sell vouchers.