FDA Approves Oral Bafiertam™ (Monomethyl Fumarate), Similar to Tecfidera® for Relapsing MS - No Launch Date Yet
May 3, 2020
The U.S. Food and Drug Administration has approved Bafiertam™ (monomethyl fumarate, Banner Life Sciences) as an oral disease-modifying therapy for people with relapsing forms of MS. Bafiertam (pronounced bah”feer’tam) is similar to Tecfidera®
and Vumerity™ but has a distinct chemical structure. No launch date has been announced yet.
- Relapsing forms of MS includes people with clinically isolated syndrome (an initial episode of neurological symptoms), relapsing-remitting MS, and active secondary progressive MS. People with active secondary progressive MS have had progression of disability but still experience acute relapses or new MRI activity.
- Although their exact mechanisms of action are not known, fumarate therapies are thought to modulate the immune response underlying MS to be less inflammatory, and may have antioxidant properties that could be protective against damage to the brain and spinal cord.
- Because of its similarity to Tecfidera, Bafiertam’s approval was based largely on the FDA’s findings of safety and efficacy for Tecfidera. Twice-daily Tecfidera was shown in clinical trials to significantly reduce relapses and disease activity on MRIs, and in one trial it reduced progression of disability.
- Bafiertam may cause serious side effects including: allergic reaction (such as welts, hives, or difficulty breathing); PML (progressive multifocal leukoencephalopathy - a rare brain infection that can lead to death or severe disability over a period of weeks or months); decreases in white blood cell count, and liver problems. The most common side effects of Bafiertam include: flushing, redness, itching, or rash; nausea, vomiting, diarrhea, stomach pain, or indigestion.
- People prescribed Bafiertam will take a lower dose for one week, and then a maintenance dose of two capsules taken by mouth twice a day.
- Once this therapy is marketed, this approval provides another treatment option for people living with relapsing forms of MS.
The prescribing information
contains details about Befiertam. Additional information on availability and cost will be provided when they become available.