Bafiertam Gets Tentative Approval for Relapsing Multiple Sclerosis
Bafiertam met the required safety, efficacy, quality, and bioequivalence standards for approval
Banner Life Sciences announced that the Food and Drug Administration (FDA) has granted tentative approval for Bafiertam (monomethyl fumarate) delayed-release 95mg capsules for the treatment of relapsing forms of multiple sclerosis (MS).
Bafiertam is a new fumarate bioequialent alternative to its prodrug, Tecfidera (dimethyl fumarate; Biogen). Its full mechanism has not been established but it is presumed to work by activating the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway.
According to the FDA, Bafiertam met the required safety, efficacy, quality, and bioequivalence standards for approval. Full approval, however, is expected after patent expiration in June 2020 or sooner depending on the outcome of pending litigation with Biogen.
“We are very pleased with the FDA's tentative approval and this important milestone brings us one step closer to providing another treatment option to patients living with relapsing-remitting multiple sclerosis,” said Franck Rousseau, MD, Chief Executive Officer of Banner Life Sciences LLC.
Biogen's Tecfidera is currently approved to treat patients with relapsing forms of MS. It is available in 120mg and 240mg delayed-release capsules.
For more information visit BannerLS.com.