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MAY 8 2026
APPROVED · 26 DAYS AGO

Genentech Ocrevus (ocrelizumab) $RHHBY

for relapsing-remitting multiple sclerosis

BLA

FDA approved Ocrevus (ocrelizumab) IV infusion for relapsing-remitting multiple sclerosis in pediatric patients aged 10 and older.

About

Multiple sclerosis is an autoimmune disease where the immune system mistakenly attacks the protective myelin coating around nerve fibers, disrupting communication between the brain and body. Ocrevus is an antibody drug that targets and depletes specific immune cells (B cells) thought to drive this harmful attack on the nervous system. By reducing these overactive immune cells, Ocrevus may help slow the progression of MS and preserve patients' physical and cognitive function.

Pivotal trial

NCT02545868 Phase 3 completed NCT02545868

This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid \[TT\]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine \[23-PPV\] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine \[13-PCV\], influenza vaccine, keyhole limpet hemocyanin \[KLH\]) after administration of a dose of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).

Source: ClinicalTrials.gov

Also in development