June 25, 2014

Health Canada Approves TECFIDERA™ As A First-Line Oral Treatment For Multiple Sclerosis

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Health Canada has approved TECFIDERA TM delayed-release capsules (dimethyl fumarate, Biogen Idec – formerly BG-12) as a first-line oral therapy for adults with relapsing-remitting multiple sclerosis (RRMS).

“We welcome the approval of an additional treatment option for people living with relapsing forms of MS,” said Sylvia Leonard, president, Ontario and Nunavut Division and national vice-president, programs and services of the MS Society of Canada. “As with any new therapy, we recommend that people with MS contact their physician to find out more information.”

About TECFIDERA: Tecfidera is indicated as monotherapy for the treatment of RRMS to reduce the frequency of relapses and to delay the progression of disability. Although the exact mechanism of action is not known, Tecfidera is thought to inhibit immune cells and molecules, and may have anti-oxidant properties that could be protective against damage to the brain and spinal cord. A chemically related compound, called Fumaderm (dimethyl fumarate and fumaric acid esters), has been used for decades in Germany to treat acute flare-ups for psoriasis. Tecfidera is a new, different formulation of dimethyl fumarate that was developed by Biogen Idec specifically for the treatment of relapsing forms of MS.

Potential Benefits: 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. Health Canada’s approval was based largely on results of two large-scale phase III studies of Tecfidera capsules, called DEFINE and CONFIRM, which were conducted in people with relapsing-remitting MS.

Potential risks and screening: The most common adverse events experienced by people taking Tecfidera during the trials were flushing (which can create a sensation of heat or itching and a red blush on the skin) and gastrointestinal events (such as diarrhea, nausea, and upper abdominal pain.) During the clinical trials, up to 40% of participants experienced flushing, and some experienced gastrointestinal events. The incidence of these events was highest in the first month of treatment, decreasing thereafter. Tecfidera reduced blood lymphocyte (white blood cells) counts but no significant or severe infections were reported. Liver enzyme tests were elevated, but there were no reports of significant liver injury or liver failure.

Selecting an MS therapy should be done by people with MS in collaboration with their MS doctors, 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. Tecfidera is not yet available in Canadian pharmacies however the MS Society of Canada will share this information as it becomes available.