Bafiertam, Oral Relapsing MS Therapy, Arrives in US
Bafiertam (monomethyl fumarate), a bioequivalent of Tecfidera to treat relapsing forms of multiple sclerosis (MS), is now available to patients in the U.S. through a network of specialty pharmacies, Banner Life Sciences, the therapy’s developer, announced.
Banner previously stated that Bafiertam would arrive on the market with the lowest price of all oral MS disease-modifying therapies, with an annualized wholesale acquisition cost (list cost) of $69,480.
“The launch of Bafiertam is a significant milestone for Banner, but more importantly it allows us to bring a new, safe and effective medicine to patients living with relapsing MS,” Franck Rousseau, MD, CEO of Banner Life Sciences, said in a press release.
“We stand ready to assist both newly diagnosed MS patients as well as those who may be considering switching from their existing therapy. Our support teams are in place to provide education and to help patients and healthcare providers navigate access and reimbursement,” Rousseau added.
Bafiertam is an alternative to Biogen’s Tecfidera (dimethyl fumarate), and was approved by the U.S. Food and Drug Administration (FDA) to treat people with clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS). Bioequivalence means that these two medications — Tecfidera and Bafiertam — provide the same amount of the active ingredient at the proper site of action and at equivalent doses.
Despite differences in their active ingredients and how they are processed once inside the body, both Bafiertam and Tecfidera can cross the blood-brain barrier to activate a transcription factor called nuclear factor (erythroid-derived 2)-like 2 (NRF2), which switches on other genes to protect neurons from oxidative stress.
The blood-brain barrier is the semi-permeable membrane that separates the brain from circulating blood, transcription factors are proteins that can control the activity of certain genes, and oxidative stress is a form of cell damage caused by the presence of oxidant molecules.
By better protecting neurons against these sources of cell damage, Bafiertam is expected to ease the symptoms and disability experienced by people with relapsing MS forms.
Due to its pharmacological similarities with Tecfidera, Bafiertam is not recommended to those who have hypersensitivity to Tecfidera or other related medications.
Banner opened a Patient Support Services center that is currently available Monday through Friday (8:30 a.m. to 8:00 p.m. ET) to provide support, and address any questions healthcare professionals or patients may have regarding Bafiertam.