FDA to consider Scripps Research drug ozanimod for treatment of multiple sclerosis
June 13, 2019
LA JOLLA, CA – The U.S. Food and Drug Administration (FDA) has accepted a New Drug Application for ozanimod, a potential treatment for multiple sclerosis that was created at Scripps Research. The pharmaceutical company Celgene, which controls the rights to the drug and filed the application, said the FDA is expected to issue its final decision on whether to approve ozanimod for relapsing forms of multiple sclerosis, the most common forms of the disease, by March 25, 2020.
“This is a major step in bringing ozanimod to patients with relapsing multiple sclerosis, providing a new treatment option that has shown great promise in clinical testing,” says Hugh Rosen, MD, PhD, who invented ozanimod along with fellow Scripps Research professor Edward Roberts, PhD.
The fundamental discoveries that led to ozanimod were reported by Rosen and colleagues in a series of papers from 2002-2008. They showed that altering the activity of certain cellular receptors could dampen the effects of the immune system, which attacks the central nervous system in patients with MS. Working with Roberts and other researchers, Rosen developed ozanimod, which binds to these receptors and inactivates immune system cells involved in MS and inflammatory bowel disease. Celgene acquired the rights to ozanimod in 2015.
The FDA application seeks approval to market the drug for relapsing and relapsing-remitting MS (RRMS). Celgene said the European Medicines Agency (EMA) has also accepted for review an application to market ozanimod for the treatment of adults with RRMS in the European Union.
The applications are based on the results of two pivotal phase 3 trials (SUNBEAM and RADIANCE Part B). Treating inflammation in RRMS patients is key to reducing their disease relapses, or “flare ups.” In the clinical trials, ozanimod significantly reduced brain lesions and brain volume loss compared with the first-line treatment, Avonex® (interferon beta-1a), in patients with RRMS.
Ozanimod is also being studied for treating forms of inflammatory bowel disease. Celgene’s phase 3 studies for ulcerative colitis, a form of the disease, are on track to be completed by mid-2020, with a subsequent filing for FDA approval expected in 2021.
For more information, contact press@scripps.edu