Ozanimod: First Approval

Ozanimod (ZEPOSIA ® ; Celgene Corporation) is a novel, orally administered sphingosine 1-phosphate (S1P) receptor modulator. In March 2020, the US FDA approved ozanimod capsules for use in the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing–remitting disease, and active secondary progressive disease, in adults. In the same month, ozanimod received a positive CHMP opinion recommending approval in the EU for the treatment of adult patients with relapsing–remitting multiple sclerosis with active disease defined by clinical or imaging features. Ozanimod is currently being evaluated for use in ulcerative colitis and Crohn’s disease in multinational phase III trials. This article summarizes the milestones in the development of ozanimod leading to its first approval for relapsing forms of multiple sclerosis.