Celgene Seeks Approval in European Union for Ozanimod to Treat Adult RRMS
An application has been submitted for the use of ozanimod to treat adult patients with relapsing-remitting multiple sclerosis (RRMS) within the European Union, according to Celgene, the developer of ozanimod.
The marketing authorization application was submitted to the European Medicines Agency (EMA).
By the end of March, Celgene intends to also apply for approval, via a new drug application to the U.S. Food and Drug Administration (FDA), of ozanimod to treat relapsing forms of MS.
Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator that causes the retention of immune cells involved in the inflammatory attacks to nerve fibers (a hallmark of the disease) in lymphoid tissues. This is thought to reduce immune cell migration into the central nervous system, preventing inflammation and loss of the protective myelin coat surrounding nerve fibers.
Ozanimod is and investigational compound currently being developed for the treatment of immune-inflammatory indications, including relapsing multiple sclerosis, ulcerative colitis, and Crohn’s disease. Ozanimod is not yet approved for any use in any country.
Positive effectiveness and safety data provided by two multicenter Phase 3 clinical trials evaluating ozanimod — SUNBEAM (NCT02294058) and RADIANCE (NCT02047734) — were the foundation for the applications to the EMA and the FDA.
The SUNBEAM and RADIANCE trials showed that ozanimod was effective in reducing the relapse rate and the number of brain lesions in RRMS patients, compared to weekly intramuscular injections of interferon beta-1a (Avonex, marketed by Biogen) or placebo.
The treatment also was shown to significantly reduce brain atrophy (shrinkage), slow disability progression, and promote significant changes in patients’ cognitive processing speed.
Ozanimod was found to be a safe and well-tolerated treatment. Common side effects reported in treated patients were mostly minor infections (nasopharyngitis, respiratory tract, and urinary tract infections ) and headache.
“Celgene believes ozanimod could be a best-in-class, oral option for use early in the treatment of relapsing forms of multiple sclerosis,” Jay Backstrom, MD, chief medical officer for Celgene, said in a press release.
“We look forward to regulatory review and the potential for ozanimod to improve the lives of people with this disease,” Backstrom added.