Bafiertam Gets Final FDA Approval for Multiple Sclerosis

The Food and Drug Administration (FDA) has granted final approval to Bafiertam™ (monomethyl fumarate; Banner Life Sciences) for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Bafiertam is a novel fumarate bioequivalent alternative to its prodrug dimethyl fumarate. The precise mechanism of action for Bafiertam has not been established but it has been shown to activate the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway. Approval of Bafiertam was based on bioavailability studies in healthy individuals comparing oral dimethyl fumarate delayed-release capsules to Bafiertam delayed-release capsules.

As both dimethyl fumarate and diroximel fumarate are metabolized to monomethyl fumarate, concomitant use with Bafiertam is contraindicated. Bafiertam may be initiated the day following discontinuation of either of these drugs.

Bafiertam will be supplied in delayed-release capsules containing 95mg of monomethyl fumarate. “We are working diligently and are eager to bring this alternative treatment to physicians and patients as soon as possible,” said Franck Rousseau, MD, Chief Executive Officer of Banner.

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