FDA Approves Bristol Myers Squibb’s Treatment for Relapsing Forms of MS

The FDA has approved Bristol-Myers Squibb’s Zeposia (ozanimod) for the treatment of adults with relapsing forms of multiple sclerosis (RMS). A Marketing Authorization Application for Zeposia in the European Union is currently under review with the European Medicines Agency (EMA), with a regulatory decision expected in the first half of 2020.

Multiple sclerosis (MS) is a disease in which the immune system attacks the protective myelin sheath that covers the nerves. The myelin damage disrupts communication between the brain and the rest of the body. Ultimately, the nerves themselves may deteriorate, a process that’s currently irreversible. RMS is characterized by clearly defined attacks of worsening neurologic function. These attacks — often called relapses, flare-ups or exacerbations — are followed by partial or complete recovery periods (remissions), during which symptoms improve partially or completely with no apparent progression of disease. Approximately 85% of MS patients are initially diagnosed with RMS.

Zeposia is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Zeposia blocks the capacity of lymphocytes to exit from the lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which ozanimod exerts therapeutic effects in MS is unknown but may involve the reduction of lymphocyte migration into the central nervous system. Zeposia is also in development for additional immune-inflammatory indications, including ulcerative colitis and Crohn’s disease.

Bristol Myers Squibb has made the decision to delay commercialization of Zeposia until a later date due to the COVID-19 pandemic. (Source: Bristol-Myers Squibb Website, 26 March, 2020)