FDA grants ‘breakthrough therapy’ designation for Roche’s experimental therapy OCREVUS™ (ocrelizumab) in primary progressive MS **UPDATE**
Update (July 6, 2016): The FDA has upgraded Roche’s application to market OCREVUS™ (ocrelizumab) for the treatment of relapsing MS and primary progressive MS to Priority Review Designation.
Priority Review Designation indicates that the FDA’s goal is to take action on an application for a new therapy within 6 months of submission (compared to 10 months under standard review). This designation is granted when the FDA considers new therapies that, if approved, would offer significant improvements in safety or effectiveness compared to standard applications. The FDA therefore expects to make a decision on the application by December 28, 2016.
The MS Society of Canada continues to monitor the status of a potential submission of Ocrevus for marketing approval to Health Canada, and will provide updates as they become available.
The U.S. Food and Drug Agency (FDA) recently granted “breakthrough therapy’ designation to ocrelizumab for the treatment of people living with primary progressive multiple sclerosis. Primary progressive MS is a form of the disease characterized by a slow accumulation of disability and for which there is currently no approved treatment. Breakthrough therapy (BT) designation is intended to fast-track the review and approvals process of drugs for serious or life-threatening conditions, and requires preliminary clinical evidence demonstrating that the therapy shows substantial improvement on at least one clinically-significant outcome measure over available therapy or no therapy. The benefit of BT designation is that a promising therapy is more likely to be available sooner to people who need it through the FDA approval process.
This announcement follows on the heels of promising results emerging from ORATORIO, a multicentre, double-blind, randomized, placebo-controlled phase III clinical trial evaluating the efficacy and safety of ocrelizumab in 732 participants living with primary progressive MS. Preliminary results were presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) conference in late 2015, and demonstrated that treatment with ocrelizumab via 2 intravenous infusions of 300mg two weeks apart significantly reduced the risk of progression of clinical disability sustained for at least 12 weeks compared with a mock treatment (placebo). Ocrelizumab was also superior to placebo in a number of secondary outcome measures (visit our emerging treatments page for more details).
These findings, together with the promising results from the OPERA I and OPERA II trials in people living with relapsing-remitting MS, have led Genetech to pursue marketing approval for ocrelizumab from the FDA for both primary progressive MS and relapsing-remitting MS.
Ocrelizumab is an investigational B cell-depleting antibody developed by Genentech, a member of the Roche group. Ocrelizumab is believed to influence the immune system response in MS by binding to CD20, a receptor found on the surface of B cells, in turn leading to the breakdown of B cells.