Zeposia (ozanimod) oral capsules continue to safely and effectively prevent relapses and disability progression in people with relapsing forms of multiple sclerosis (MS), according to three-year data from a Phase 3 extension clinical trial.
“Gaining insight into long-term therapeutic outcomes can enable clinicians to identify the most appropriate treatment approach for their multiple sclerosis patients,” Bruce Cree, MD, PhD, said in a press release. Cree is the trial’s investigator and clinical research director at University of California San Francisco (UCSF) MS Center,
“The DAYBREAK trial provides us with important context regarding the longer-term efficacy and safety profile of Zeposia,” added Cree, who also is a professor of clinical neurology at UCSF Weill Institute for Neurosciences.
The findings will be presented in a poster titled “Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis in DAYBREAK: an open-label extension study of ozanimod phase 1−3 trials,” (abstract #P0217) at the MSVirtual2020 meeting set for Sept. 11–13.
The MSVirtual2020 is a joint Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) online conference.
Zeposia is a sphingosine-1-phosphate (S1P) receptor modulator developed by Celgene, a subsidiary of Bristol Myers Squibb. It works by preventing immune cells from leaving the lymph nodes, entering circulation, and reaching the brain and spinal cord, where they can promote further inflammation and nerve cell damage.
It is approved in the U.S. for the treatment of relapsing forms of MS — including relapsing-remitting MS (RRMS), active secondary progressive MS (SPMS), and clinically isolated syndrome — and in the European Union for active RRMS.
Both approvals were based on positive data from the global Phase 3 SUNBEAM (NCT02294058) and RADIANCE part B (NCT02047734) clinical trials. Results showed that Zeposia was superior to Avonex in lowering annualized relapse rates (ARR) — the number of relapses per year — and brain lesions for up to two years in people with RRMS or active SPMS.
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