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Celgene Joins Troubled MS Club With Refuse To File For Ozanimod From US FDA

 
• By Jessica Merrill

Other multiple sclerosis contenders – including Sanofi's Lemtrada, Acorda's Ampyra, and Merck KgAA's cladribine – have also been RTFed. Question now for Celgene is how long the delay will be. 

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A refuse to file letter for a late-stage blockbuster contender like Celgene Corp.'s ozanimod is always embarrassing, but they aren't entirely uncommon from the US FDA, particularly when it comes to multiple sclerosis. Three other MS drugs filed in the last 10 years also received RTFs, with a varying degree of delays and outcomes. The question now is which path ozanimod will take.

Celgene announced the regulatory update on ozanimod Feb. 27 after market close, sparking a sell-off as investors reacted to more disappointing news from a company that's recently had several setbacks....

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