Celgene Resubmits Multiple Sclerosis Drug NDA for FDA Approval

March 29, 2019

This week, drug maker Celgene resubmitted its New Drug Application (NDA) to the FDA for RPC-1063 (Ozanimod), seeking an indication for the treatment of adults with relapsing multiple sclerosis.

This week, drug maker Celgene resubmitted its New Drug Application (NDA) to the FDA for RPC-1063 (Ozanimod), seeking an indication for the treatment of adults with relapsing multiple sclerosis.

“New oral treatment options with differentiated profiles like ozanimod are needed to help address an unmet need for people with relapsing forms of MS,” said Jay Backstrom, MD, chief medical officer for Celgene in a statement.

Just over a year ago, the FDA issued a “refusal-to-file” letter on the NDA, which is submitted “when the NDA is incomplete because it does not on its face contain information required,” under certain statues of the Federal Food, Drug, and Cosmetic Act.

Specifically, the refusal to file was due to shortcomings found in the preclinical and clinical pharmacology parts of the NDA package submitted by Celgene.

The resubmission comes as Bristol-Myers Squibb (BMS) is in the process of acquiring Celgene for $74 billion. However, the acquisition has seen some hurdles as BMS shareholders have spoken out about some hesitancy in moving forward with the deal.

The acquisition adds nearly $32 billion worth of debt to BMS’ budget while assuming $20 billion of Celgene’s debt. Wellington Management, the largest institutional holder of BMS’ common stock at around 8%, said in a press release that it “does not believe that the Celgene transaction is an attractive path,” and went on to say that “the transaction asks BMY shareholders to accept too much risk.”

Should the deal move forward, the fate of Celgene’s ozanimod submission could affect how much BMS pays for Celgene. BMS had agreed to $50 per share with an additional $8 per share if the FDA approves ozanimod, JCAR017, and bb2121 by the end of 2020. Though this feat would still have some way to go, the resubmission of ozanimod to the FDA would potentially clear the first hurdle.

Earlier this month, Celgene also submitted a Marketing Authorization Application to the European Medicines Agency for ozanimod seeing an indication for the treatment of adults with relapsing-remitting multiple sclerosis.