UPDATE: FDA-Approved Oral Bafiertam™ (Monomethyl Fumarate) Now Available for Prescription
September 1, 2020
(Originally released in May 3, 2020; Updated with additional details)
The U.S. Food and Drug Administration approved Bafiertam™ (monomethyl fumarate, Banner Life Sciences) in late April 2020 as an oral disease-modifying therapy for adults with relapsing forms of MS. Bafiertam (pronounced bah”feer’tam) is similar to Tecfidera® and Vumerity® but has a distinct chemical structure. This therapy is now available for prescription.
>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 and “bioavailability” studies in healthy subjects comparing dimethyl fumarate to Bafiertam. 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.
>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.
>The price of Bafiertam has been announced as $69,480 per year. The actual cost to individuals will depend on the provisions of their insurance coverage and the degree to which they will be eligible for programs designed to assist with out-of-pocket costs.
More info:
https://www.nationalmssociety.org/Ab...ethyl-Fumarate)
September 1, 2020
(Originally released in May 3, 2020; Updated with additional details)
The U.S. Food and Drug Administration approved Bafiertam™ (monomethyl fumarate, Banner Life Sciences) in late April 2020 as an oral disease-modifying therapy for adults with relapsing forms of MS. Bafiertam (pronounced bah”feer’tam) is similar to Tecfidera® and Vumerity® but has a distinct chemical structure. This therapy is now available for prescription.
>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 and “bioavailability” studies in healthy subjects comparing dimethyl fumarate to Bafiertam. 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.
>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.
>The price of Bafiertam has been announced as $69,480 per year. The actual cost to individuals will depend on the provisions of their insurance coverage and the degree to which they will be eligible for programs designed to assist with out-of-pocket costs.
More info:
https://www.nationalmssociety.org/Ab...ethyl-Fumarate)
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