Ozanimod evaluated as a treatment for multiple sclerosis and inflammatory bowel disease.
Celgene Corporation announced it received a refusal to file letter from the FDA for a new drug application (NDA) for ozanimod for relapsing forms of multiple sclerosis (MS), according to a company press release.
Ozanimod is an investigational oral selective sphingosine 1-phosphate 1 and 5 receptor modulator that is being explored for the treatment of MS and other autoimmune conditions, including Crohn’s disease and ulcerative colitis.
The FDA rejected the application on the grounds of insufficient non-clinical and clinical pharmacology information for a review, according to the release.
Celgene plans to request a Type A meeting with the FDA to determine which information is required to resubmit the application for ozanimod. The drug has yet to be approved in any country, according to the release.
"We remain confident in ozanimod's clinical profile demonstrated in the pivotal program in relapsing forms of multiple sclerosis," said Jay Backstrom, MD, chief medical officer and head of Global Regulatory Affairs, Celgene, said in the release. "We will work with the FDA to expeditiously address all outstanding items and bring this important medicine to patients."
In February 2017, Celgene announced phase 3 findings that suggest ozanimod could reduce the frequency of relapse.
Related Coverage: Ozanimod Reduces Frequency of Relapsing Multiple Sclerosis
The randomized, double-blind, double-dummy, active-controlled, phase 3 SUNBEAM study compared ozanimod with interferon β-1a (Avonex) in 1346 patients with relapsing MS. The results of the study showed that ozanimod met its primary endpoint in reducing the annualized relapse rate of relapsing MS compared with interferon β-1a.