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European Commission Approves Bristol Myers' Zeposia - Quick Facts

Bristol Myers Squibb (BMY) announced Wednesday that the European Commission (EC) has approved Zeposia (ozanimod) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.

With the EC marketing authorization, Zeposia, an oral medication taken once daily, becomes the only approved sphingosine-1-phosphate (S1P) receptor modulator for RRMS patients with active disease.

Zeposia is the only approved S1P receptor modulator that offers RRMS patients with active disease an initiation with no first-dose observation required for the majority of patients. It binds with high affinity to S1P receptors 1 and 5. It blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood.

The approval is based on data from the randomized, active-controlled Phase 3 SUNBEAM and RADIANCE Part B clinical trials, which enrolled more than 2,600 patients across 150 sites in more than 20 countries.

The trials showed that, as compared to AVONEX (interferon beta-1a), Zeposia delivered powerful efficacy as measured by annualized relapse rate (ARR), as well as on the number and size of brain lesions.

Multiple sclerosis (MS) is a disease in which the immune system attacks the protective myelin sheath that covers the nerves, creating damaging lesions that make it harder for signals to travel between each nerve cell. This "signal breakdown" can lead to symptoms and relapses.

Multiple sclerosis is an unpredictable and often disabling disease that affects about 700,000 people in Europe and approximately 2.5 million people worldwide.

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