Genentech and Roche Secure FDA Approval of Multiple Sclerosis Drug Ocrevus

On March 28, 2017, the U.S. Food and Drug Administration (FDA) approved the use of Ocrevus (ocrelizumab) in treating multiple sclerosis (MS). Ocrevus is a new biologic and is the first drug approved by the FDA to treat primary progressive multiple sclerosis (PPMS), one of the most disabling forms of MS, as well as relapsing forms of multiple sclerosis (RMS). Ocervus was originally developed by Genentech and has been acquired by Roche.

Ocrevus is classified as an infusion immunosuppressant drug that uses humanized monoclonal antibodies designed to selectively target CD20-positive B-cells. While most current MS drugs are targeted at T-cells that attack the myelin sheaths protecting nerves, Ocrevus targets B-cells that are thought to help orchestrate the T-cell’s attack. Rituximab, a previous non-humanized version of the monoclonal antibody, has been used off label to treat difficult cases of MS, but its use was not developed as a treatment for MS likely due to patent issues and a soon to expire patent term.[1]

The FDA approved Ocrevus based on data from two RMS Phase III studies, OPERA I and OPERA II, and a separate PPMS Phase III study, ORATORIO. The OPERA trials compared the efficacy of Ocrevus to Rebif (interferon beta-1a), another MS drug, in people with RMS. The ORATORIO trial compared the efficacy of Ocrevus against placeo in people with PPMS. According to a Genentech Press Release,[2]

OCREVUS was the first and only treatment to significantly slow disability progression and reduce signs of disease activity in the brain (MRI lesions) compared with placebo with a median follow-up of three years. A similar proportion of people in the OCREVUS group experienced adverse events and a low rate of serious adverse events compared with people in the placebo group in the PPMS study.

Ocrevus is listed in the Purple Book, a list of biological products for licensing similar to the Orange Book, under the Biologic License Application Submission Tracking Number (BLA STN) 761053.[3]

Ocrevus arose out of research from Dr. Stephen Hauser at the University of California, San Francisco.[4] Dr. Hauser discovered that T-cells were not alone in attacking the nervous system of patients with MS, but that B-cells also helped fuel the attack. According to Stat News[5] Ocrevus will be priced at an annual price of $65,000 for the twice a year infusions.