Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted a new drug application (NDA) for Ozanimod. The FDA had previously rejected Celgene’s NDA for Ozanimod, citing insufficient data. The FDA is expected to accord regulatory approval of Ozanimod on March 25, 2020. The EMA is also expected to announce its regulatory decision in the first half of 2020.
How Ozanimod works
In multiple sclerosis (MS), inflammation caused by the body’s immune system can result in damage to the myelin sheath. The myelin sheath is essential to protect and insulate nerve fibers in the brain and spinal cord.
Ozanimod belongs to a class of drugs known as selective sphingosine 1-phosphate (S1PR1) and 5 (S1PR5) receptor modulators. S1PR1 modulators interfere with S1P signaling and block immune cells (lymphocytes) from exiting the lymph nodes and entering tissues such as the brain and spinal cord. This keeps the immune cells, such as T cells and B cells, trapped inside the lymph node, reducing or preventing the attack of the myelin sheath by these cells.
Ozanimod in clinical trials
In September 2016, Celgene announced positive results from its Phase 2 clinical trial (NCT01628393) called RADIANCE. Findings demonstrated that ozanimod was effective in reducing total brain lesions, as determined by magnetic resonance imaging (MRI) scans, after 24 weeks of treatment. Results of a nearly two-year safety and efficacy extension study further emphasized the potential of ozanimod in treating patients with RRMS. Commonly reported side effects were mostly minor infections (nasopharyngitis, respiratory tract and urinary tract infections) and headache, with no reports of new safety or tolerability issues.
The Phase 3 portion of the RADIANCE study (NCT02047734) began in 2013 by Receptos (now owned by Celgene) under a special protocol assessment with the FDA. This trial evaluated the efficacy, safety, and tolerability of two oral doses of ozanimod (0.5 mg and 1 mg) against weekly intramuscular (into the muscle) injections of Avonex (interferon beta-1a) or placebo in approximately 1,200 RRMS patients over 24 months of treatment. Both ozanimod doses met the study’s primary endpoint of reducing annualized relapse rates.
Another Phase 3 trial called SUNBEAM (NCT02294058) compared the safety and effectiveness of oral ozanimod (0.5 mg and 1 mg doses) with Avonex in 1,346 RRMS patients. Results showed that treatment with ozanimod, at either dose, produced both statistically significant and clinically meaningful improvements in treated patients compared to Avonex. Ozanimod-treated patients also showed significant and meaningful improvements in the trial’s secondary objectives as well at month 12, and again at month 24.
Pooled data from the RADIANCE and SUNBEAM trials showed that ozanimod significantly reduced brain atrophy compared to Avonex and had similarly low rates of disability progression.
A Phase 3 open-label extension study (NCT02576717) is further evaluating ozanimod’s safety and efficacy in RRMS patients who had participated in earlier ozanimod trials — an estimated 2,350 people. This trial is expected to be completed in June 2020.
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