FDA Approves First Drug to Treat Two Forms of MS
On March 28, 2017, the United States Food and Drug Administration (FDA) announced the approval of Ocrevus™ (ocrelizumab) for the treatment of two types of multiple sclerosis (MS): relapsing forms of MS (RMS) and primary-progressive MS (PPMS). This is the first time that a medication for MS has been approved for these two types of the disease, and the first time that any medication has been approved to treat PPMS. This is very exciting news for the MS community. To view the FDA’s press release, please visit www.fda.gov and search for “new drug Ocrevus,” which will bring up the press release titled “FDA approves new drug to treat multiple sclerosis.”
Prior to this approval, 14 disease-modifying therapies were available for the treatment of relapsing forms of MS, but no treatments had been approved by the FDA for PPMS. As noted, the approval is for relapsing forms of MS (RMS), which are characterized by sudden flare-ups and remissions. RMS includes relapsing-remitting MS (RRMS) as well as secondary-progressive MS (SPMS) with relapses. The approval is also for primary-progressive MS (PPMS), which is a less-common form of the disease and is characterized by a steady accumulation of symptoms.
Medication and Study Information
Developed by Genentech, a member of the Roche group, Ocrevus™ (ocrelizumab) is a humanized monoclonal antibody designed to selectively target CD20-positive B cells. These are a specific type of immune cell that is an important contributor to the MS-disease process. The fact that Ocrevus targets B cells differentiates it from most of the previously approved disease-modifying therapies for MS, which target a different type of immune cell called “T cells.”
In Phase III trials, 600 mgs of Ocrevus were given via intravenous (IV) infusion every six months. In most instances, the initial 600-mg dose was divided into two 300-mg doses, given via IV infusion, and separated by two weeks.
Positive results were seen in three Phase III trials with Ocrevus. OPERA I and OPERA II were studies with relapsing forms of MS. Compared to treatment with Rebif® (interferon beta-1a), Ocrevus showed greater efficacy in reducing annualized relapse rates and reducing disability progression that was sustained for time periods of at least three and at least six months.
The ORATORIO study was with PPMS and compared treatment with placebo. The trial showed significant reductions in disability progression sustained for time periods of at least three and at least six months. Reductions in other measures of progressive disease were also seen. In all three studies, Ocrevus reduced the burden of MS lesions as shown on magnetic resonance imaging (MRI).
Adverse events in all three of the Phase III studies were similar between those given Ocrevus and those given either Rebif in the RMS studies or the placebo in the PPMS study. Genentech reports that the most common adverse events seen with Ocrevus were mild to moderate infusion-related reactions and infections. Other rare adverse events, including cancer and progressive multifocal leukoencephalopathy (PML), could potentially occur, but the risk is low and still being investigated. As of the time of approval, no cases of PML had occurred.
Comment from MSAA’s Chief Medical Consultant
MSAA’s Chief Medical Consultant Dr. Jack Burks explains, “This is one of the most exciting times for the MS community. The addition of this new medication to our current group of approved disease-modifying therapies gives a new option for the treatment of MS, particularly for individuals with PPMS as well as others with relapsing MS whose disease activity could not be well-controlled with other therapies. In addition, the approval of Ocrevus and the results of these studies will help guide future MS research into the disease process and the development of other innovative treatment strategies.”
For More Information
For more information about Ocrevus, please call (844) OCREVUS [or (844) 627-3887] or visit www.ocrevus.com. Genentech also plans to offer patient-assistance programs through Genentech Access Solutions. For more information, please call (866) 4ACCESS [or (866) 422-2377] or visit www.Genentech-Access.com.
For additional information on MS 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 Dr. Jack Burks, MSAA’s Chief Medical Consultant