FDA Refuses Celgene Submission for MS Drug

FDA has issued Celgene a refusal-to-file letter on an NDA for ozanimod for treating patients with relapsing forms of multiple sclerosis. In the letter, the agency said its preliminary review determined that the nonclinical and clinical pharmacology sections in the submission were insufficient to permit a complete review, according to the company. Celgene intends to seek immediate guidance, including a Type A meeting request with FDA to understand what additional information will be required in a resubmission.

Ozanimod is a novel, oral, selective sphingosine 1-phosphate 1 and receptor modulator that is also being studied for ulcerative colitis and Crohn’s disease. “Selective binding with [sphingosine 1-phosphate 1] is believed to inhibit a specific sub set of activated lymphocytes from migrating to sites of inflammation,” Celgene says. “The result is a reduction of circulating T and B lymphocytes that leads to anti-inflammatory activity.”