Celgene Corp. submitted a marketing authorization application to the European Medicines Agency for its drug ozanimod to treat a disease affecting the central nervous system.
The Summit, N.J.-based biopharmaceutical company is seeking approval for ozanimod in treating adults with relapsing-remitting multiple sclerosis, or disease that alternates between symptoms worsening and disappearing. Multiple sclerosis is a potentially disabling nervous system disease that affects the communication of information between the brain and the body.
The application is based on late-stage studies known as Sunbeam and Radiance, which evaluated the effectiveness and safety of ozanimod.
Celgene said it remains on track to submit a new drug application to the U.S. Food and Drug Administration for relapsing forms of multiple sclerosis by the end of March. Ozanimod, which has been framed as one of the next big revenue drivers for Celgene, was rejected by the FDA in February 2018 — a decision that came as a surprise to company executives.
Ozanimod is an investigational compound that has yet to receive approval in any territory. The drug is being developed for immune-inflammatory indications including ulcerative colitis and Crohn's disease — two types of inflammatory bowel diseases.