FDA Approves Twice a Day Dose of Dimethyl Fumarate for MS


FDA Approved March 2013 Dimethyl Fumarate CAS 624-49-7The recent approval of dimethyl fumarate CAS# 624-49-7, on March 27th, 2013, was an encouraging sign for the 2.5 million patients worldwide who are suffering with Multiple Sclerosis. The FDA approved Tecfidera, the brand name for dimethyl fumarate, which is developed by Biogen. As easy to dispense oral capsules, this new treatment for MS is expected to become a pharmaceutical star. Projections from analysts are more than promising, with some analysts indicating that dimethyl fumarate will be the number one medication to treat Multiple Sclerosis and gross three billion dollars in sales yearly.

The need for a novel and efficacious treatment for MS is long awaited. Dimethyl fumarate has proven to be particularly effectual for patients with relapsing forms of MS. As a chronic autoimmune disease, Multiple Sclerosis is an inflammatory condition that affects the central nervous system of the patient. The communication between the brain and body becomes awry, and symptoms such as muscle weakness and decreased balance and coordination become chronic. Multiple Sclerosis holds the title of being the most common cause of neurological disability in young adults, with women making up more of this patient population as compared to men. Patients typically undergo periods of time deemed to be relapses and recovery. The relapse period for patients involves severely decreased functioning both neurologically and physically, and as time progresses the recovery periods get shorter. Studies of Tecfidera, or dimethyl fumarate, showed a significant amount of patients experienced decreases in relapses of their MS symptoms, as compared to those patients who were dosed with the placebo. The patients who received dimethyl fumarate benefited greatly by this drug, with their average relapse rate cut by 49% after a two year period of study. The studies thus far have been for patients with elapsing-remitting MS, which is the most common form of MS that is diagnosed. This specific form is often characterized by flare-ups followed by periods of remission.  Roughly 85% of people with Multiple Sclerosis are diagnosed with this form of MS.

Patients who were administered dimethyl fumarate appreciated the simple twice a day dose schedule. Prior treatments for Multiple Sclerosis have been offered as infused or injectables only, such as Avonex, Copaxone (see article highlighting the favorable outcomes for patients taking Copaxone) and Tysabri. The adverse effects are limited, with the main concern being that dimethyl fumarate can decrease the white blood cell counts of patients, which raises their risk of infection. Patients who receive treatment with this powerhouse medication should be monitored closely by their physician as to their lymphocyte count. Side effects that are more common include diarrhea, flushing and nausea. Side effects from dimethyl fumarate have shown to decrease over time.

Annette Funicello Multiple SclerosisThe loss of beloved Mousketeer Annette Funicello to complications from Multiple Sclerosis has been in the headlines as of late. Her struggle with this virulent disease took its toll on her, and while none of her fans know her exact symptoms, her family has stated that MS affected her in a profound way.

There is currently no cure for Multiple Sclerosis on the horizon, so treatments like dimethyl fumarate are essential for this struggling patient population.

LGM Pharma provides dimethyl fumarate for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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  • EU Approves Dimethyl Fumarate for First Line MS Treatment
    Posted on April 9, 2014 at 9:42 am

    […] has been the number one prescribed oral therapy for MS and RRMS in the United States since it’s FDA approval in March of 2013. This powerhouse therapy has also been approved in Canada and Australia since […]

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