The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
MAY 8 2026
APPROVED · 84 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 attacks the protective myelin sheath around nerve cells, disrupting signal transmission and causing symptoms like vision loss and muscle weakness. Ocrevus is an antibody that targets and depletes specific B cells of the immune system. By reducing these cells, the drug may lower the immune attack on myelin, potentially reducing disease activity for people with MS.

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