The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
MAY 8 2026
APPROVED · 144 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 in which the immune system attacks myelin, the protective insulation around nerve cells, disrupting how the central nervous system transmits signals and causing symptoms such as vision loss, muscle weakness, and problems with sensation and coordination. Ocrevus is an antibody given by infusion that binds to CD20, a protein on the surface of certain immune B cells, and removes them from circulation. Because those B cells are thought to drive the myelin attack, depleting them may reduce relapses and slow the nerve damage that builds up over time.

Pivotal trial

NCT04966338 Phase 3 completed NCT04966338

The purpose of this study is to evaluate the efficacy and safety of Ocrelizumab produced by CinnaGen compared with Ocrevus® (Roche, Switzerland) in subjects with relapsing remitting multiple sclerosis (RRMS). All the participants will receive one of the following regimens: Ocrelizumab (CinnaGen) or Ocrevus® (Roche, Switzerland) ,600 mg (given as dual infusions of ocrelizumab 300 mg on Days 1 and 15 of the first 24-week treatment cycle and as single infusions of 600 mg on Day 1 for each 24-we...

Source: ClinicalTrials.gov

Also in development