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BMS's Zeposia (ozanimod) Receives the CHMP's Positive Opinion to Treat Adults with Relapsing-Remitting Multiple Sclerosis with Active Disease

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BMS's Zeposia (ozanimod) Receives the CHMP's Positive Opinion to Treat Adults with Relapsing-Remitting Multiple Sclerosis with Active Disease

Tuba Khan

BMS's Zeposia (ozanimod) Receives the CHMP's Positive Opinion to Treat Adults with Relapsing-Remitting Multiple Sclerosis with Active Disease

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  • The approval is based on P-III SUNBEAM & RADIANCE Part B studies assessing Zeposia (0.92 mg and 0.46 mg- equivalent to 1 mg and 0.5 mg ozanimod HCI) vs Avonex (qw- IM) in 1-346 & 1-320 patients with RMS for at least 12 & 24mos. treatment period respectively
  • The results will further be reviewed by the European Commission- which has the authority to approve medicines for the European Union
  • Zeposia (ozanimod) is an oral S1P receptor modulator involved in binding with S1P receptors 1 and 5. On Mar 25- 2020 the US FDA approved Zeposia for the treatment of adults with relapsing forms of multiple sclerosis (RMS)

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