FDA, EMA Accept Applications for Ozanimod to Treat Relapsing Forms of MS

Both the FDA and the European Medicines Agency have accepted applications to review ozanimod, an oral sphingosine 1-phosphate (S1P) receptor modulator, for the treatment of relapsing forms multiple sclerosis (MS).

Ozanimod is an investigational drug that is not currently approved in any country. Data from SUNBEAM and RADIANCE, which are multicenter, randomized, double-blind, double-dummy, active-controlled trials, were included with the applications. These trials found that patients treated with ozanimod lost less cortical grey matter volume, which is associated with long-term physical disability and cognitive issues in MS, than patients treated with interferon β-1a. Ozanimod also significantly reduced the annualized relapse rate.

The trials also found that ozanimod reduced magnetic resonance imaging lesions in both early and more advanced relapsing MS and was also associated with improved cognitive speed and higher rates of no evidence of disease activity.

“These analyses provide additional encouraging data for ozanimod in relapsing multiple sclerosis, from its potential to influence cognitive processing to showing results in patients with either early or more advanced forms of the disease,” Jay Backstrom, MD, chief medical officer for Celgene, said in a statement in 2018. “Ozanimod has the potential to offer the multiple sclerosis community a new oral option for the treatment of relapsing multiple sclerosis, and we continue to work with regulatory bodies in the U.S. and EU in our efforts to bring this treatment to patients.”

SUNBEAM included 1346 patients in 20 countries and compared ozanimod with interferon β-1a. In RADIANCE, 2 oral doses of ozanimod were compared with interferon β-1a in 1320 patients in 21 countries.

Ozanimod works by binding to S1P subtypes 1 and 5. In addition to being in development for relapsing MS, it is also being studied to treat other immune-inflammatory conditions, such as ulcerative colitis and Crohn disease.

“We believe that ozanimod has the potential to be an important option early in the treatment of relapsing forms of MS and a best-in-class S1P receptor modulator,” Backstrom said in a statement after the applications for ozanimod were accepted by both agencies.