The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both agreed to review for possible approval ozanimod, Celgene‘s investigational oral therapy for relapsing forms of multiple sclerosis (MS).
An FDA decision on the company’s New Drug Application for ozanimod is expected on or before March 25, 2020. A ruling on the Marketing Authorization Application given the EMA — specifying approval as a treatment for relapsing-remitting MS (RRMS) — is likely in the first half of 2020, Celgene announced in a press release.
Ozanimod, formerly known as RPC1063, is an immunomodulator compound that works by selectively binding to sphingosine 1-phosphate (S1PR1) and 5 (S1PR5) receptors, preventing immune cells from entering the brain and causing inflammation.
Both regulatory submissions, made in March, were based on promising data from two multicenter, randomized, double-blind, and active-controlled trials: the SUNBEAM Phase 3 study (NCT02294058), and Part B of the RADIANCE Phase 2/3 trial (NCT02047734).
SUNBEAM compared the effects of ozanimod to those of Avonex (an injectable formulation of interferon beta-1a by Biogen) in treating people with relapsing forms of MS. The study enrolled 1,346 patients, who were randomly assigned to either ozanimod capsules (0.5 mg or 1.0 mg daily doses) or Avonex weekly injections for at least one year.
Results showed that people treated with ozanimod experienced fewer MS relapses and brain lesions, as well as clinically meaningful improvements in processing speed, compared to those treated with Avonex.
RADIANCE was a 120-week, two-part trial assessing the safety and efficacy of ozanimod in treating adults with relapsing-remitting MS (RRMS) compared to placebo.
In Part A (NCT01628393), 258 RRMS patients were randomly assigned to either ozanimod, at 0.5 mg or 1.0 mg once-a-day, or a placebo for 24 weeks. Results showed that ozanimod-treated patients had a lower number of brain lesions from week 12 to week 24, assessed by magnetic resonance imaging (MRI), and fewer MS relapses compared to those treated with a placebo.
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