Ocrevus Approved for Multiple Sclerosis
March 28, 2017 – The U.S. Food and Drug Administration (FDA) approved Ocrevus™ (ocrelizumab) manufactured by Genenetech, a member of the Roche Group. Ocrevus is an intravenous (IV) medication used to treat both primary progressive multiple sclerosis (PPMS) and relapsing forms of the disease (RMS). It is the first drug approved for treating PPMS. Ocrevus is a monoclonal antibody that disrupts the activity of CD20-positive B cells, which play a role in damaging nerve cells (axons) and their coverings (myelin sheaths). The launch is expected within two weeks at an annual cost of $65,000. Recommended dosing is one infusion of 600mg given by a health professional every six months after the first two doses of 300mg, each administered two weeks apart. Ocrevus will be available through a limited network of specialty pharmacies.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.