Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval of ZEPOSIA® (ozanimod) for the Treatment of Adult Patients with Relapsing Remitting Multiple Sclerosis with Active diseaseDetails Hits: 101
PRINCETON, NJ, USA I March 27, 2020 IBristol Myers Squibb (NYSE:BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for ZEPOSIA® (ozanimod) for the treatment of adult patients with Relapsing Remitting Multiple Sclerosis (RRMS) with active disease as defined by clinical or imaging features. ZEPOSIA is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
“This positive CHMP opinion reinforces that ZEPOSIA has the potential to become an important treatment option for patients with Relapsing Remitting MS with active disease. There remains a need for effective and safe therapies that impact both the relapses and brain lesions that are characteristic of this disease,” said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. “We look forward to the European Commission’s decision and the potential to bring ZEPOSIA to patients in the EU.”
The CHMP adopted the positive opinion 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 U.S. Food and Drug Administration (FDA) approved ZEPOSIA for the treatment of adults with relapsing forms of Multiple Sclerosis (RMS) on March 25, 2020.
SUNBEAM is a pivotal, phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of two doses of oral ZEPOSIA (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI, respectively) against weekly intramuscular AVONEX® (interferon beta-1a) for at least a 12-month treatment period. The study included 1,346 people living with RMS across 152 sites in 20 countries.