Celgene refiles potential MS blockbuster ozanimod with FDA

Celgene has filed its highly anticipated oral MS drug ozanimod with the US regulator, more than a year after the FDA rejected it because of a bureaucratic foul-up. Last February Celgene received a “Refuse to File” notice from the FDA after finding issues with the dossier submitted by the company’s Receptos unit, which first developed the drug. After the rejection, a top executive from Celgene pinned the blame on Receptos for a substandard filing. Nadim Ahmed said he regretted that the big US pharma had taken an arms-length relationship with Receptos after its acquisition in 2015 for $7.2 billion. Without Celgene overseeing the dossier, Ahmed said Receptos had failed to provide the necessary preclinical and clinical pharmacology information on the MS drug. Celgene will be hoping the issues are in the past with its new filing for ozanimod in relapsing forms of the disease, which is tipped for annual sales in the region of $5 billion, although a newly-approved rival in the shape of Novartis’ rival pill Mayzent (siponimod) could make this much harder to achieve.