Ocrelizumab: Pediatric First Approval.

Ocrelizumab, a recombinant humanized IgG1 monoclonal antibody directed against CD20-expressing B-cells, has been developed by Genentech, Inc. for the treatment of multiple sclerosis (MS). Both intravenous infusion and subcutaneous injection formulations of ocrelizumab are approved in the EU and the USA for the treatment of adults with relapsing or primary progressive forms of MS. In May 2026, the intravenous infusion formulation of ocrelizumab (OCREVUS®) was approved in the USA for the treatment of relapsing-remitting MS (RRMS) in pediatric patients 10 years of age and older who weigh 25 kg or more. This article summarizes the milestones in the development of ocrelizumab leading to this first pediatric approval for RRMS.