Celgene can breathe a sigh of relief as FDA accepts once-spurned ozanimod application — setting a target date on a blockbuster decision
For most major biopharmas, having your NDA accepted for review is a non-event. At Celgene and Bristol-Myers Squibb this morning, it’s cause for celebration.
The big biotech reported that both the FDA as well as the EMA have accepted their application for ozanimod, an experimental therapy for multiple sclerosis. That’s by no means a guarantee of approval, but it does set the clock ticking on a major regulatory decision that is central to the success of the $74 billion Celgene buyout by Bristol-Myers Squibb.
The PDUFA date on this one now sits with a March 25, 2020 deadline for the key regulatory decision in the US. The EMA’s answer will come in the first half of next year.
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