Bafiertam™ (monomethyl fumarate)

FDA-Approved Medications: Medications Recently Approved

Company: Banner Life Sciences

  • Starting dose: 95 mg twice a day, orally, for 7 days
  • Maintenance dose after 7 days: 190 mg (administered as two 95 mg capsules) twice a day, orally
  • Approved in April 2020 for relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary-progressive disease, in adults.

Previous: Zeposia® (ozanimod) | Next: Vumerity® (diroximel fumarate)

Bafiertam™ (monomethyl fumarate) is an oral medication taken twice daily for relapsing forms of MS. It is a fumarate-type medication, as is Tecfidera® (dimethyl fumarate). Bafiertam secured FDA approval after its developer, Banner Life Sciences, demonstrated that the medication is a “bioequivalent alternative” to Biogen’s Tecfidera, meaning that the active ingredient and site of action do not differ significantly between the two medications.3, 5

The issue of bioequivalence is important because Tecfidera has demonstrated efficacy in treating relapsing forms of MS but can cause significant gastrointestinal (GI) effects – including nausea, vomiting, and diarrhea – in some patients.4 As a result, drug developers have sought to find formulations of fumarate medications that offer similar efficacy but have fewer GI side effects. These efforts include Biogen partnering with Ireland-based Alkermes to develop the recently approved Vumerity® (diroximel fumarate), as detailed below, and Banner Life Science’s development of Bafiertam.

The starting and maintenance doses of Bafiertam are lower than those for Tecfidera.4, 5 With the daily doses assumed to be equivalent in terms of their efficacy, the hope is that the reduced amount of Bafiertam will result in fewer GI side effects while providing similar benefit against relapses and other manifestations of MS. Although not studied in MS patients, a recent study compared the gastrointestinal tolerability of Bafiertam to Tecfidera in 210 healthy adults without MS. The five-week study has been completed, but results were not posted at the time of this writing.22, 23

The exact mechanism of action by which fumarate 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.

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).5

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.3

Previous: Zeposia® (ozanimod) | Next: Vumerity® (diroximel fumarate)