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Celgene files with US FDA for approval of MS treatment following 2018 rejection

Celgene Corp. has again filed with the U.S. Food and Drug Administration for approval of its multiple sclerosis treatment ozanimod just over a year after an initial rejection from the agency.

The FDA issued a refusal-to-file letter for ozanimod in February 2018, requiring more nonclinical and clinical pharmacological information.

The New Jersey company based the newest filing on data from two late-stage studies called Sunbeam and Radiance, both of which reached their primary goals.

Celgene also filed with the European Medicines Agency for ozanimod earlier in March.

"New oral treatment options with differentiated profiles like ozanimod are needed to help address an unmet need for people with relapsing forms of MS," Celgene Chief Medical Officer Jay Backstrom said in a March 25 press release.

Ozanimod is predicted to be a pillar of revenue for Celgene and the company's prospective acquirer Bristol-Myers Squibb Co. The deal is valued at $95 billion and is expected to close in the third quarter pending shareholder approval.

Celgene expects sales of its best-selling cancer drug Revlimid to erode as exclusivity ends in 2026, and executives on the most recent earnings call said they look to drugs like ozanimod to fill the gap.

Bristol-Myers has also alluded to the lineup of prospects in Celgene's pipeline to support the acquisition.