Vumerity™ Oral Capsules Approved by the FDA for Adults with Relapsing Forms of MS, Including Active SPMS
Reviewed by MSAA Chief Medical Officer Barry A. Hendin, MD
On October 30, 2019, Biogen Inc. and Alkermes plc announced the United States Food and Drug Administration (FDA) approval of Vumerity™ (diroximel fumarate) oral capsules to treat adults with relapsing forms of multiple sclerosis (MS). This approval includes the treatment of clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary-progressive MS (SPMS). Vumerity’s effectiveness and safety in children has not been studied and is not known at this time. This medication is taken by mouth twice daily.
Marketed through a collaboration between Biogen Inc. and Alkermes plc, Vumerity is in the same class of MS therapy as Biogen’s Tecfidera® (dimethyl fumarate), but is believed to cause fewer gastrointestinal (GI) side effects – such as diarrhea, nausea, vomiting, and abdominal pain. The exact mechanism of action by which Vumerity exerts therapeutic effect in MS is not completely understood. However, upon entering the body, the medication is rapidly converted into the molecule monomethyl fumarate, which is the same active component found in Tecfidera. The monomethyl fumarate molecule is thought to activate an antioxidant protein that reduces oxidative stress, which in turn slows damage to protective nerve fibers in the brain.
In February of this year, the FDA accepted a New Drug Application (NDA) for the approval of Vumerity. As part of the submission, study results comparing Vumerity to Tecfidera were included to establish bioequivalence, which refers to having the same active ingredients and resulting in similar effectiveness, safety, and side effects. However, the “distinct chemical structure” of Vumerity that converts to the same active molecule as Tecfidera, reduces the incidence of gastrointestinal side effects.
According to Biogen Inc. and Alkermes plc, “The key components of the EVOLVE-MS (Endeavoring to Advance Treatment for Patients Living with Multiple Sclerosis) clinical development program of Vumerity include the EVOLVE-MS-1 study, a Phase III, open-label, two-year safety study in relapsing-remitting multiple sclerosis patients, along with pharmacokinetic bridging studies comparing Vumerity and Tecfidera to demonstrate bioequivalence. The EVOLVE-MS clinical development program also includes the EVOLVE-MS-2 study, an elective Phase III, five-week randomized, prospective, double-blind, multi-center study that assessed the gastrointestinal (GI) tolerability of Vumerity and Tecfidera using self-administered GI questionnaires.”
Interim results from the EVOLVE-MS-1 study included a low rate of participants who stopped taking the medication due to adverse events (6.3%) and an even lower rate (1%) of individuals who stopped due to gastrointestinal (GI) events. The pharmaceutical companies also note, “Additional exploratory efficacy endpoints in the ongoing EVOLVE-MS-1 study showed changes in clinical and radiological measures compared to baseline.”
According to MSAA’s MS Research Update published earlier this year, “The ongoing open-label EVOLVE-MS-1 trial is assessing the safety/tolerability and efficacy of diroximel fumarate [Vumerity] over 96 weeks in 503 individuals with relapsing MS (RMS). Those study subjects include both newly diagnosed patients (people who were diagnosed with MS less than one year before study entry and who have not had a prior disease-modifying therapy [DMT]) and those with more long-standing RMS. All participants in the Phase III trial receive 462 mg of diroximel fumarate [Vumerity] twice daily.
“Interim results from the Phase III study were reported at the American Academy of Neurology’s 2019 Annual Meeting, held in Philadelphia in May. Data covering 48 weeks of treatment showed that relapse rates fell approximately 80% among the entire study group relative to baseline. In addition, the number of gadolinium-enhancing lesions seen on MRI was reduced by 77% from baseline for the entire group and by 96% from baseline for the individuals who were newly diagnosed.”
Warnings, side effects, and adverse events are similar to those listed for Tecfidera. Individuals who have had an allergic reaction to any ingredient of Vumerity should not take this medication. Individuals with liver problems, kidney problems, with low white blood cell counts or infection, as well as those who are pregnant, breastfeeding, or plan to become pregnant or breastfeed, should speak with their healthcare provider before taking Vumerity. Allergic reactions, PML (progressive multifocal leukoencephalopathy), decreases in white blood cell counts, and liver problems are among the potential serious adverse events that could occur. Common side effects include flushing, redness, itching, or rash; nausea, vomiting, diarrhea, stomach pain, or indigestion. Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time. Patients should not drink alcohol at the time they are taking a dose of Vumerity.
MSAA’s Chief Medical Officer Barry A. Hendin, MD, explains, “Vumerity is a new therapeutic option for people with MS. While its efficacy is comparable to Tecfidera, this newly approved medication has a lower incidence of gastrointestinal side effects. These types of side effects have been an obstacle for some clinicians and their patients who would otherwise benefit from this therapeutic mechanism.
“Vumerity is the third disease-modifying therapy (DMT) to be approved in 2019. We anticipate additional approvals in the coming year, and we welcome these new agents that provide new and valuable treatment options for the MS community.”
For more information about Vumerity, please visit www.vumerity.com. Individuals may also call (800) 456-2255 to reach Above MS™, Biogen’s support-services program.
For More Information
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 Wells Courtney, MSAA Senior Writer
Excerpts from MSAA’s 2019 MS Research Update Written by Tom Garry, Medical Writer
Reviewed by Dr. Barry A. Hendin, MSAA Chief Medical Officer
