HIGH POINT – Banner Life Sciences, a privately held specialty pharmaceutical company based in High Point, has gained final regulatory approval of a drug for treating multiple sclerosis.
The U.S. Food and Drug Administration approved Bafiertam (monomethyl fumarate), delayed-release capsules that target relapsing forms of MS.
“The FDA’s final approval marks an important milestone for Banner and for patients living with relapsing-remitting multiple sclerosis,” Franck Rousseau, M.D., chief executive officer of Banner, said in a news release. “We are working diligently and are eager to bring this alternative treatment to physicians and patients as soon as possible.”
The approval came after Banner won a patent dispute this month with Biogen, maker of Tecfidera (dimethyl fumarate), the top-selling MS drug, which is manufactured at Biogen’s Research Triangle Park facility. The U.S. Court of Appeals upheld a prior ruling last year by the U.S. District Court for the District of Delaware that Banner had not infringed on Biogen’s patent protecting Tecfidera.
The FDA had granted tentative approval of Bafiertam in November 2018 under a New Drug Application. However, final approval was pending either the expiration of Biogen’s patent this June or the outcome of the patent litigation between Banner and Biogen.
Bafiertam is a novel fumarate bioequivalent alternative to Tecfidera that met the FDA’s required bioequivalence, safety, efficacy and quality standards for approval.
“As a practicing neurologist treating patients with MS, I’m encouraged that a lower dose of Bafiertam is equivalent to Tecfidera and may possibly lead to improved gastrointestinal tolerability for patients, especially early in the treatment regimen,” said Daniel Wynn, M.D. FACNS FAASM, director of clinical research and director of consultants in neurology at the Multiple Sclerosis Comprehensive Care Center in Chicago.
Relapsing-remitting multiple sclerosis is the most common form of MS, a debilitating autoimmune disease characterized by inflammatory attacks on the central nervous system followed by periods of remission. The relapsing-remitting form affects about 85 percent of patients diagnosed with MS, or an estimated 2 million people worldwide, according to the National Multiple Sclerosis Society.
MS has no known cure. Disease progression and degree of impairment vary widely by patient, depending on the location and extent of nerve damage.
Treatment regimens for the relapsing-remitting form focus on managing symptoms, slowing disease progression and reducing relapses.
Bafiertam has been shown to activate an MS disease pathway known as the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, but its precise mechanism of action has not been fully elucidated, according to Banner.
(C) NC Biotech Center