Celgene refiles ozanimod with FDA 1 year after regulatory snafu

Celgene has refiled for FDA approval of ozanimod in multiple sclerosis. The resubmission comes one year after Celgene was rocked by a refusal-to-file notice from the FDA. 

The FDA hit Celgene with the notice a little more than 12 months ago due to shortcomings in the preclinical and clinical pharmacology parts of its package. Celgene looked to some ongoing clinical pharmacology programs for data to address the FDA’s demands but hopes of a rapid resolution to the logjam faded quickly. 

Celgene’s resubmission took a little more than a year but, as promised, the big biotech got its filing back in front of the FDA by the end of the first quarter. The timing sets Celgene up to bring the drug to market next year.

By then, Celgene could be part of Bristol-Myers Squibb. The fate of ozanimod will play a role in how much Bristol-Myers ultimately pays for Celgene. Having offered $57 a share in cash for Celgene at one point in the negotiations, Bristol-Myers ultimately signed off on $50 a share and a further $8 a share if FDA approves ozanimod, JCAR017 and bb2121 by the end of 2020.

Celgene still has a long way to go to pull off that triple approval but getting the ozanimod filing back in front of the FDA clears the first small hurdle. 

The original filing for FDA approval of ozanimod was a low point for Celgene in a bad period for the company. The regulatory misstep hurt Celgene’s reputation, further pressured its share price and enabled Novartis to steal a lead in the race to bring a SP1 drug to market, denting the prospect of ozanimod living up to its billing as a big blockbuster. And in the aftermath, Celgene’s Nadim Ahmed laid the blame for the snafu at Receptos’ door.