The U.S. Food and Drug Administration (FDA) approved Bafiertam in April as a bioequivalent to Biogen’s Tecfidera (dimethyl fumarate). Bioequivalence means that the two medications provide the same amount of the active ingredient at the proper site of action and at equivalent doses.
“We are very pleased to bring this important new treatment option and value to patients, payers and healthcare providers, and we will launch Bafiertam with the lowest price among oral MS disease-modifying therapeutics at an annualized WAC price of $69,480,” said Franck Rousseau, CEO of Banner, in a press release.
“This pricing reflects a significant reduction in cost of approximately 20% for Vumerity and 30% for Tecfidera,” Rousseau added.
Biogen had earlier taken Banner to court over Bafiertam, arguing that it infringed upon Biogen’s patent for Tecfidera.
The U.S. District Court for the District of Delaware ruled in favor of Banner in January, deciding that Bafiertam did not infringe upon Biogen’s patent. The United States Court of Appeals for the Federal Circuit then upheld this decision in April. Final FDA approval had been paused, pending this decision.
Bafiertam’s active ingredient is monomethyl fumarate, whereas Tecfidera consists of dimethyl fumarate, which the body metabolizes into monomethyl fumarate.
Although the mechanism of action of both medications is not completely understood, both appear to cross the blood-brain barrier, where they activate a transcription factor called nuclear factor (erythroid-derived 2)-like 2 (NRF2), which may further activate other genes that protect neurons from oxidative stress. Inflammation and oxidative stress both damage the protective myelin sheath of nerve fibers, contributing to disability and other MS symptoms.
Because of its chemical similarity to Tecfidera, Bafiertam is not recommended for patients with a known hypersensitivity to Tecfidera or related therapies.
“Bafiertam provides a new, safe and effective medication for both newly diagnosed MS patients and those considering switching to a new therapy,” said Daniel Wynn, MD, director of clinical research, director consultants in Neurology Multiple Sclerosis Comprehensive Care Center in Chicago.
“Bafiertam’s tolerability profile, flexible dosing, and lower cost will be embraced by patients, their physicians, and payers,” Wynn added.
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