FDA Approves Vumerity (Diroximel Fumarate) for Relapsing Forms of MS
This week, the United States Food and Drug Administration (US FDA) approved the use of Vumerity (diroximel fumarate) for the treatment of relapsing forms of MS. Vumerity is manufactured by Biogen Inc. and Alkermes plc, and is indicated for relapsing forms of MS, including clinically isolated syndrome, active secondary progressive disease, and relapsing-remitting disease. Another drug similar to Vumerity, called Tecfidera (dimethyl fumarate), is already on the market, but may cause gastrointestinal upset that is hard to tolerate. Both medications are types of drugs called fumarates, however, each has its own distinct chemical structure. Vumerity’s different chemical structure was thought to potentially cause fewer gastrointestinal side effects (like nausea or stomach pain) than Tecfidera, and the two medications were tested head-to-head.
Clinical trials with Vumerity
Several years of clinical trials that focused on the effectiveness, safety, and side effects of Vumerity led up to its recent approval. Ultimately, Vumerity was found to be just as effective in treating relapsing forms of MS as Tecfidera. When it came to safety and side effects, Vumerity also showed promise. Specifically, clinical trials within a program called EVOLVE-MS were started to learn more about Vumerity. Although one phase-3, two-year trial is still ongoing, almost 700 individuals with relapsing forms of MS have participated so far. Overall, only about 6% of all participants stopped taking Vumerity due to side effects, and only 1% of these were due to adverse gastrointestinal side effects.
How is Vumerity similar to Tecfidera?
The FDA approved Vumerity after determining it was bioequivalent to Tecfidera and just as safe. When two drugs are bioequivalent, it means they contain the same active ingredient and have similar effects on the body. However, even when two drugs are bioequivalent, they may have different side effects. In this case, while both drugs may have similar clinical effects, Vumerity may cause fewer gastrointestinal-related side effects. Although Vumerity isn’t meant to replace Tecfidera, it does provide individuals with another treatment option in case they are unable to tolerate Tecfidera due to gastrointestinal distress. Both Tecfidera and the newly approved Vumerity are thought to reduce the inflammatory response in the body, as well as to protect nerve cells in the central nervous system to improve symptoms related to MS.
Possible side effects of Vumerity
Vumerity is indicated for use by adults only. The most common side effects encountered with Vumerity include redness, flushing, itching, and rash. Although gastrointestinal issues may occur less frequently with Vumerity when compared to Tecfidera, gastrointestinal issues are still possible. These include diarrhea, stomach pain, indigestion, nausea, or vomiting. Other side effects such as an allergic reaction, liver issues, a decreased number of white blood cells, and a brain infection called PML (progressive multifocal leukoencephalopathy) may occur, but these are very rare. If you are interested in taking Vumerity, your doctor or healthcare provider can help determine which side effects you may be at risk for, and if Vumerity is appropriate for your specific situation.
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