Ozanimod: First Approval

Compliance with Ethical Standards

Funding: The preparation of this review was not supported by any external funding.

Conflict of interest: During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. Yvette Lamb is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.

Additional information about this Adis Drug Review can be found here

Abstract

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 defned 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 frst approval for relapsing forms of multiple sclerosis.