BMS' Zeposia (ozanimod) Receives the US FDA's Approval as New Oral Treatment for Relapsing Forms of Multiple Sclerosis
Shots:
- The approval is based on P-III SUNBEAM & RADIANCE Part B studies assessing Zeposia (0.92 mg- equivalent to 1mg) vs Avonex (interferon beta-1a- qw- IM) in 1-346 & 1-320 patients with RMS for at least 12 & 24mos. treatment period respectively
- Collective results: @1yr. & @2yrs.; reduction in ARR of 48% & 38% (0.18 vs 0.35 & 0.17 vs 0.28); reduction in T1-weighted GdE brain lesions (0.16 vs 0.43 & 0.18 vs 0.37)- reduction in number of new or enlarging T2 lesions (1.47 vs. 2.84 & 1.84 vs 3.18) respectively
- Zeposia is an S1P receptor modulator that binds with high affinity to S1P receptors 1 and 5- act by blocking the capacity of lymphocytes to egress from lymph nodes thus reducing the number of lymphocytes in peripheral blood
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