The U.S. Food and Drug Administration (FDA) has given final approval to Banner Life Sciences’ Bafiertam (monomethyl fumarate), a bioequivalent alternative to Biogen’s Tecfidera (dimethyl fumarate) to treat people with relapsing multiple sclerosis (MS).
“The FDA’s final approval marks an important milestone for Banner and for patients living with relapsing-remitting multiple sclerosis,” Franck Rousseau, MD, CEO of Banner, said in a press release. “We are working diligently and are eager to bring this alternative treatment to physicians and patients as soon as possible.”
Bafiertam, a delayed-release capsule treatment, was given tentative approval by the FDA in November 2018, noting it satisfied the bioequivalence, safety, efficacy, and quality standards required for approval. Bioequivalence means that equal doses of two medicines provide the same amount of the active ingredient at the proper site of action.
Final approval was pending the June expiration of a U.S. patent protecting Tecfidera, as well as litigation between Banner and Biogen regarding the patent.
The U.S. District Court for the District of Delaware ruled in favor of Banner in January, deciding that Bafiertam did not infringe upon the patent. This decision was upheld by the United States Court of Appeals for the Federal Circuit in April.
The active ingredient of Bafiertam is monomethyl fumarate. Tecfidera is quickly converted from dimethyl fumarate into monomethyl fumarate in the body. Patients treated with Tecfidera, however, have reported a range of gastrointestinal side effects, such as indigestion, nausea, diarrhea, vomiting, and abdominal pain.
Banner sponsored a Phase 1 clinical trial (NCT04022473) comparing the gastrointestinal tolerability of Bafiertam to Tecfidera in 210 healthy adults. Participants were randomly assigned to one of the two oral therapies, and followed for five weeks, as gastrointestinal side effects typically appear in the first weeks of treatment.
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