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Home Industry News Biogen receives positive opinion on Tecfidera

Biogen receives positive opinion on Tecfidera

27th March 2013

Biogen has announced it has received a positive opinion from the Committee for Medicinal Products for Human Use in the European Union for its Tecfidera treatment.

The biotechnology company confirmed the first-line oral medication for adults with relapsing-remitting multiple sclerosis was approved by the body on the basis of quality, safety and efficacy.

As a result, the recommendation will now be referred to the European Commission, which grants marketing authorization for medicines in the European Union.

In addition, the US Food and Drug Administration is predicted to come to a conclusion on the marketing application for the product in the US over the coming weeks.

George Scangos, chief executive officer of Biogen, said the recommendation brings the company one step closer to offering multiple sclerosis patients a new treatment option in the convenience of a pill.

He added: "We believe Tecfidera will raise expectations for what people living with multiple sclerosis can achieve with their therapy."ADNFCR-8000103-ID-801563091-ADNFCR

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