FDA Extends Review of Ocrevus™ (ocrelizumab)
On December 20, 2016, Genentech, a member of the Roche group, announced that the United States Food and Drug Administration (FDA) had extended the review period of Ocrevus™ (ocrelizumab) for the treatment of relapsing forms of MS (RMS) and primary-progressive MS (PPMS). This extension was needed to allow more time for the FDA to review data on the manufacturing process of this potential therapy. The extension is not related to any details involving the safety or effectiveness of Ocrevus.
In June, 2016, Genentech announced that the Biologics License Application (BLA) for ocrelizumab had been accepted for review by the FDA, and also submitted the brand name Ocrevus™ for use with ocrelizumab. Additionally, the FDA granted Priority Review Designation of the application, with a targeted action date of December 28, 2016. This means that the review of the application was expected to be completed by this date, as well as a decision on whether or not this investigational medication is approved. The new targeted action date is March 28, 2017.
If approved, Ocrevus would be the first medication available for both RMS and PPMS. Presently, 14 disease-modifying therapies are available for the treatment of relapsing forms of MS, but no treatments have been approved by the FDA for PPMS, which is a less-common form of the disease. PPMS is characterized by a steady accumulation of symptoms, versus sudden flare-ups and remissions.
Ocrevus is a humanized monoclonal antibody designed to selectively target CD20-positive B cells. This is a specific type of immune cell that is an important contributor to the MS-disease process. Ocrevus is given via intravenous (IV) infusion every six months.
Positive results were seen in all three Phase III trials with Ocrevus, which include reduced annualized relapse rates (in studies with relapsing forms of MS) and reduced disability progression (in studies with relapsing forms of MS as well as studies with progressive MS). Reductions in other measures of progressive disease were also seen. Genentech reports that the most common adverse events seen with this medication were mild to moderate infusion-related reactions and infections.
While the extended review period for Ocrevus is disappointing, readers may note that eligible individuals with PPMS may receive this medication through an Expanded Access Program (EAP). An EAP enables participants to receive an investigational medication that has not yet been approved by the Unites States Food and Drug Administration (FDA). This program is a nontraditional study that has no placebo group, so all those enrolled are given the active medication. It follows a strict protocol that has been developed through consultation with the FDA. This program is limited to only eligible people with PPMS and not for anyone with a relapsing form of MS. For more information, please see MSAA’s article, “Eligible People with PPMS May Receive Experimental Medication.”
For specific questions about Ocrevus, please contact Genentech’s Trial Information Support Line (TISL) at (888) 662-6728, or their Patient Resource Center at (877) 436-3683.
For general information or to speak with a trained Client Services Specialist, please call MSAA’s Helpline at (800) 532-7667, extension 154. Questions to MSAA’s Client Services department may also be emailed to MSquestions@mymsaa.org.
Written by Susan Courtney, MSAA Senior Writer
Reviewed by Jack Burks, MD, MSAA Chief Medical Consultant