Bafiertam Oral Capsules Approved by the FDA for Relapsing Forms of MS

Updated May 15, 2020

Reviewed by MSAA Chief Medical Officer Barry A. Hendin, MD

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. Since a lower dose of Bafiertam is equivalent to Tecfidera, this may potentially lead to a reduction in gastrointestinal (GI) side effects, such as diarrhea, nausea, vomiting, and abdominal pain. However, these side effects have not been evaluated in clinical trials in people with relapsing forms of MS.

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.

According to the prescribing information for Bafiertam, the starting dose is one 95-mg oral capsule taken twice daily for the first seven days. The maintenance dose after seven days is two 95-mg capsules (for a total of 190 mg) taken twice daily. The prescribing information also warns not to crush, chew, or mix contents of the delayed-release oral capsules with food. However, Bafiertam may be taken with or without food.

Bafiertam’s effectiveness and safety in children has not been studied and is not known at this time. Women who are pregnant or could become pregnant should consult with their healthcare provider, since adequate data is not available on its effects to an unborn child or if the medication may be passed into breast milk.

Warnings, side effects, and adverse events are similar to those listed for Tecfidera. Bafiertam is contraindicated in patients with known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or to any of its inactive ingredients. Allergic reactions, PML (progressive multifocal leukoencephalopathy), herpes zoster and other serious opportunistic infections, decreases in white blood cell counts, and liver injury, are among the potential serious adverse events that could occur. Blood tests, including a complete blood count (CBC) and lymphocyte count, need to be performed prior to starting treatment, six months after starting treatment, and every six to 12 months thereafter (as well as when clinically indicated).

According to Banner, Bafiertam may cause flushing, which may be experienced as warmth, redness, itching, and/or a burning sensation. In clinical trials with Tecfidera, 40% of treated patients experienced flushing, which in most cases was mild to moderate in severity. As noted earlier, other common side effects include: redness, itching, or rash; nausea, vomiting, diarrhea, stomach pain, or indigestion. Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time.

MSAA’s Chief Medical Officer Barry A. Hendin, MD, explains, “The therapeutic options for people with relapsing forms of MS continue to expand. We expect the number of medications for these forms of MS, and possibly for progressive forms of the disease as well, to continue to increase in the coming year. This is always great news for the MS community! However, the unmet need still remains in identifying treatments that repair and provide additional neuroprotection for the central nervous system in people with multiple sclerosis.”

For More Information

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Written by Susan Wells Courtney, MSAA Senior Writer
Reviewed by Dr. Barry A. Hendin, MSAA Chief Medical Officer