The United States Food and Drug Application has approved the review of the new drug application of Celgene’s ozanimod. The review application was also approved by the European Medicines Agency. The drug is indicated for treating relapsing-remitting multiple sclerosis in Europe whereas it is approved for relapsing forms of multiple sclerosis in the United States.
Ozanimod was an oral-dosage sphingosine 1-phosphate (S1P) receptor modulator. The action date in the United States is March 25, 2020, whereas EMA decision is expected in the first half of 2020.
The safety and efficacy of the product are assessed using two trials.
SUNBEAM:
Phase 3 trial evaluating the safety, efficacy, and tolerability of two doses (0.92 mg and 0.46 mg) involving 1,346 people.
Primary endpoint annualized relapse rates (ARR) during the treatment period.
RADIANCE:
Phase 3 trial evaluating the safety, efficacy, and tolerability. Ozanimod was compared with interferon beta-1a over a period of 24 hours.
The primary endpoint was ARR. The study 1,320 people across 21 countries.