FDA turns down Celgene’s high-profile MS drug

Feb 28, 2018

Celgene reported this week that the FDA won’t review an application for ozanimod, an experimental treatment for multiple sclerosis.

The news comes as a blow to the company who had hoped the drug would help diversify its portfolio and net the company up to $5 billion in sales per year. Ozanimod became an even more important drug for the company last year after the development for a Chron’s disease medication was abandoned. 

According to Celgene, the FDA said the company had failed to provide sufficient “nonclinical and clinical pharmacology” information with its application. The company plans to meet with the agency to determine what it can do to continue moving the drug through the regulatory approvals process.

Read the full report in Stat.