Biogen Idec: EU Oks Tecfidera As First-Line Oral Treatment For MS - Quick Facts

Biogen Idec (BIIB) said Monday that the European Commission has approved Tecfidera (dimethyl fumarate) as a first-line oral treatment for people with relapsing-remitting multiple sclerosis or RRMS, the most common form of multiple sclerosis or MS. The company said it will begin to introduce Tecfidera in initial European Union or EU countries in the coming weeks.

Tecfidera was first approved in the United States in March 2013 and became the country's number one prescribed oral therapy for relapsing forms of MS after six months. Tecfidera was also approved in Canada and in Australia in 2013.

The European Commission approval was based on a robust clinical development program that included two global Phase 3 clinical trials, DEFINE and CONFIRM, as well as an ongoing extension study, ENDORSE, in which some patients have been followed for up to six and a half years.

The company stated that Tecfidera has been clinically shown to significantly reduce important measures of disease activity, including relapses and the development of brain lesions, as well as to slow disability progression, while demonstrating a favorable safety and tolerability profile.

Tecfidera is the fourth therapy Biogen Idec offers to people living with MS.

Tecfidera (dimethyl fumarate) gastro-resistant hard capsules are indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis. Tecfidera has been shown to reduce multiple sclerosis relapses and MS brain lesions, as well as to slow the progression of disability, while demonstrating a favorable safety and tolerability profile.

According to the EU Summary of Product Characteristics (SmPC), the starting dose of TECFIDERA is 120 mg twice a day orally. After seven days, the recommended dose should be increased to 240 mg twice a day.

The company said that Tecfidera is not recommended during pregnancy or in women of child bearing potential not using appropriate contraception.

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