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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.  
The prescribing information contains details about Bafiertam for healthcare professionals.
The patient information contains information about taking Bafiertam for people with MS.
 
The most common possible side effects of Bafiertam include:
  • Flushing, 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. Taking Bafiertam without food may reduce the incidence of stomach problems.
Possible serious side effects include:
  • Allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing)
  • PML, a rare brain infection that usually leads to death or severe disability
  • Decreases in white blood cell counts (which can decrease the ability to fight infections). Your healthcare provider should do a blood test before you start treatment and while on therapy.
  • Liver problems. Your healthcare provider should do blood tests to check for liver function before you starting and during treatment if needed. Symptoms to look for related to liver problems during treatment include:
    • severe tiredness
    • loss of appetite
    • pain on the right side of your stomach
    • have dark or brown (tea color) urine
    • yellowing of your skin or the white part of your eyes  
  • Herpes zoster infections (shingles), including central nervous system infections
  • Other serious infections  
People with MS and healthcare professionals interested in additional information about Bafiertam and support services may call 1-855-3BANNER (1-855-322-6637), Mon.-Fri. from 8:30am-8:00pm Eastern Time.
 
Note on starting a disease-modifying therapy during the COVID-19 pandemic: Many experts believe it is safe to start a disease-modifying therapy, including fumarates, during the COVID-19 pandemic. This therapy may increase your risk of infections, including COVID-19. The limited evidence available suggests that people with MS taking fumarate medications do not have an increased risk of more severe COVID-19 symptoms or death.
 
Taking a disease-modifying therapy is currently the best way to reduce MS disease activity and future deterioration. Selecting any therapy should be done by people with MS in collaboration with their MS healthcare providers, taking into account a variety of factors, including the effectiveness of any therapy they are currently using, and weighing potential risks and benefits, costs and lifestyle factors.
 
 
Bafiertam is a trademark of Banner Life Sciences LLC
Tecfidera and Vumerity are registered trademarks of Biogen

 

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis, and there is currently no cure for MS. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. An estimated 1 million people live with MS in the United States. Most people with MS are diagnosed between the ages of 20 and 50, and it affects women three times more than men.

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