Is Ocrevus Approved for Primary Progressive MS?
Yes, Ocrevus (ocrelizumab) is FDA-approved for treating primary progressive multiple sclerosis (PPMS) in adults. The approval came in March 2017 as the first drug specifically for this form of MS, based on the phase 3 ORATORIO trial showing it slowed disability progression by 24% over 120 weeks compared to placebo.[1][2]
How Does Ocrevus Work in PPMS?
Ocrevus targets CD20-positive B cells, depleting them to reduce inflammation and neurodegeneration in PPMS. In ORATORIO, it reduced confirmed disability progression (CDP) risk by 24% (hazard ratio 0.76) and improved scores on the timed 25-foot walk.[1] It's given as two 300 mg IV infusions every 6 months after initial doses.
What About Relapsing Forms of MS?
Ocrevus is also approved for relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS), making it the first drug for both relapsing and progressive disease. Trials like OPERA I/II confirmed superior efficacy over interferon beta-1a in reducing relapses.[1][3]
Common Side Effects and Risks
Patients report infusion reactions (up to 40%), infections (34%), and upper respiratory issues. Serious risks include progressive multifocal leukoencephalopathy (PML) and hepatitis B reactivation. Monitoring for infections and vaccinations is required before starting.[1][2]
Who Makes Ocrevus and Cost Considerations?
Genentech (a Roche subsidiary) manufactures Ocrevus. U.S. list price is about $65,000 per year, though patient assistance programs exist. Patents extend protection until at least 2032 in some territories; check DrugPatentWatch.com for expiry details and generics.[4]
Alternatives for PPMS Treatment
Few options exist: Mayzent (siponimod) is approved for active SPMS but not primary progressive. Off-label uses include mitoxantrone or stem cell therapy. No cures; treatments focus on slowing progression.[1][3]
Sources:
[1] FDA Label: Ocrevus Prescribing Information
[2] NIH: Ocrevus for PPMS
[3] NEJM: ORATORIO Trial
[4] DrugPatentWatch: Ocrevus