On April 30, 2020, Banner Life Sciences LLC (Banner), a privately held specialty pharmaceutical company, announced the United States Food and Drug Administration (FDA) approval of Bafiertam™ (monomethyl fumarate) delayed-release oral capsules to treat relapsing forms of multiple sclerosis (MS). This approval includes the treatment of clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary-progressive MS (SPMS). Banner has not yet announced when the medication will be available to the MS community.
Bafiertam is a “bioequivalent alternative” to Biogen’s Tecfidera® (dimethyl fumarate), which means that the active ingredient and site of action do not differ significantly between the two medications. The therapeutic effect is assumed to be equivalent. Similar to Vumerity™ (diroximel fumarate), which was approved in October 2019 and is also in the same class of MS therapy as Tecfidera, Bafiertam is believed to cause fewer gastrointestinal (GI) side effects. Examples of these side effects include diarrhea, nausea, vomiting, and abdominal pain. This reduction in GI symptoms may especially occur early in the treatment regimen.
The exact mechanism of action by which these medications exert their therapeutic effect in MS is not completely understood. However, the monomethyl fumarate molecule is thought to activate an antioxidant protein that reduces oxidative stress, which in turn slows damage to protective nerve fibers in the brain. Clinical trials with Tecfidera showed a reduction in relapse rate, a delay in progression of physical disability, and a slowing in the development of brain lesions, as compared to placebo. Click on link to read the article in its entirety: Bafiertam