2020/03/30Zeposia (Ozanimod) Receives FDA Approval for Multiple Sclerosis
On March 25, 2020, the U.S. Food and Drug Administration (FDA) approved Zeposia (ozanimod), a new Class 1 drug, for the treatment of relapsing multiple sclerosis. Developed by Celgene, Zeposia (ozanimod) is the first new drug approved by the U.S. FDA since Bristol-Myers Squibb completed its acquisition of Celgene. Zeposia is available as a standard capsule in strengths of 0.23 mg, 0.46 mg, and 0.92 mg. The dosing regimen involves taking 0.23 mg orally on days 1–4, 0.46 mg orally on days 5–7, and 0.92 mg orally daily starting on day 8. Clinical indications include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Ozanimod exhibits high oral bioavailability, with a Tmax of approximately 6–8 hours post-oral administration and a mean elimination half-life of 21 hours.