(Healthline) – Vew oral treatment for relapsing forms of multiple sclerosis has been approved by the Food and Drug Administration (FDA).
Biogen Inc. and Alkermes plc announced the approval of Vumerity this week, making it the 18th FDA-approved treatment for multiple sclerosis (MS).
Vumerity is expected to be similar in results to Tecfidera, another Biogen treatment for MS — but with fewer side effects.
“Both drugs use a unique mechanism of action that is not offered by other treatments,” Kathy Costello, a nurse practitioner at the Johns Hopkins Multiple Sclerosis Center in Maryland and the vice president of healthcare access for National Multiple Sclerosis Society, told Healthline.
Past research has shown that Tecfidera has success on multiple sclerosis with a 53 percent reduction of relapses, 38 percent reduction in the likelihood of disability progression, and 90 percent reduction on active contrast MRI lesions.
However, “Tecfidera has bad side effects, especially in the beginning,” noted Costello. “Vumerity is different and has less gastrointestinal problems.”
Costello explained that people with uncomfortable side effects may not adhere to a treatment.
Considered a follow-up drug to Tecfidera, doctors predict better adherence with Vumerity due to the fewer side effects.
Details on the drugs
The active ingredient in Vumerity is diroximel fumarate, which is rapidly converted to monomethyl fumarate in the body.
Tecfidera is a dimethyl fumarate and also converts to monomethyl fumarate.
“[The drugs] become identical in what they do in the body. But, how they get there is different,” explained Costello.
“We expect Vumerity to provide the same benefits as Tecfidera, but we are waiting [on] results,” Dr. Barry Singer, neurologist at Missouri Baptist Medical Center in St. Louis, a trial site for the EVOLVE-MS study, told Healthline.
Singer is also the director and founder of The MS Center for Innovations in Care.
“The research I presented at ECTRIMS in September 2019 showed approximately 30 percent of those on Vumerity had gastrointestinal side effects but less than 1 percent discontinue due to this side effect,” Singer told Healthline. “The full results from the EVOLVE-MS trials are pending.”
Vumerity is approved for clinically isolated syndrome (CIS), relapsing-remitting MS, and active secondary progressive MS.
It’s not approved for primary progressive or secondary progressive MS that’s not active.
But, “it may work for other forms of MS,” said Costello.
“We want the DMTs to be a positive experience,” Singer said. “Vumerity provides another option for MS.”