New MS Drug, Vumerity, Approved by FDA – Everyday Health

The U.S. Food and Drug Administration (FDA), on October 30, 2019, approved a new option in the treatment of multiple sclerosis (MS): Vumerity (diroximel fumarate), which is manufactured by the drugmaker Biogen.

The new drug is indicated for the treatment of relapsing-remitting MS (RRMS) and active secondary-progressive MS as well as management of clinically isolated syndrome (CIS), a first episode of neurologic symptoms that may be an early sign of MS. According to a press release issued by the company, Biogen holds the exclusive, worldwide license to commercialize the new drug and intends to make it available in the United States in the near future.

Were very lucky in that I think this is the 17th medication available now to treat relapsing-remitting MS, notes Robert Bermel, MD, the director and staff neurologist at the Mellen Center for Multiple Sclerosis at the Cleveland Clinic in Ohio. We now know that MS is much more common than originally thought, and its not a one-size-fits-all condition, meaning it affects different people differently. Therefore, were very fortunate that we have a lot of options for treating MS.

According to Dr. Bermel, like its predecessor drug Tecfidera (dimethyl fumarate, also manufactured by Biogen), once ingested, Vumerity is designed to convert rapidly to monomethyl fumarate in the body. Unlike the older drug, approved in 2013, however, it may have fewer gastrointestinal (GI) side effects, he says.

As noted in the prescribing information for Tecfidera, GI side effects like abdominal pain, diarrhea, nausea, and vomiting were reported in as many as 18 percent of people taking the drug in clinical trials. Conversely, in aclinical trial of Vumerity, published on November 4 in Multiple Sclerosis Journal, fewer than 1 percent of people taking the drug discontinued treatment because of GI-related side effects.

I dont know if its going to become the most commonly prescribed MS drug out there, Bermel says. But even if its a niche therapy that gives us an opportunity to help a select group of the more than 1 million Americans with MS, its very important.

Because of its favorable side effect profile, Bermel believes Vumerity may be an option for people with RRMS who have other conditions, such as high blood pressure, heart disease, or diabetes, that complicate use of other disease-modifying therapies (DMTs) or for those who are prone to infections and may be at greater risk for them while on other MS-modifying immune therapies, he says.

Every patient Ive ever talked to, the first question they ask is, What are the side effects? Bermel notes. Unfortunately, questions like What benefit should I expect? seem to take a backseat sometimes.

What should people who take Vumerity expect from the new drug? Once released to the market, it will be available in capsules of 231 milligrams. The recommended starting dose is one capsule taken twice a day. After seven days, the dose is increased to two capsules taken twice a day.

Like all DMTs, its designed to prevent relapses, disability progression, and the appearance of MRI lesions on the brain in people with RRMS, Bermel says. People taking it might not notice a difference in their symptoms from one day to the next, but they should experience fewer relapses.

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New MS Drug, Vumerity, Approved by FDA - Everyday Health