Biogen’s MS drug moves closer to regulatory approval in Europe

Biogen Idec Inc., the Cambridge biotechnology firm that already makes the multiple sclerosis drugs Avonex, Tysabri, and Tecfidera, said Friday that its new MS drug is potentially closer to market approval in Europe.

The new drug is called Plegridy, and it could broaden the company’s arsenal of MS treatments. Some MS drugs have to be injected daily or once a week. Plegridy would be injected once every two weeks, meaning that it has the potential to be a more convenient option for adults who have relapsing-remitting multiple sclerosis. (Tecfidera, in contrast, is pill taken twice a day. Tysabri is a once-a-month infusion for patients with severe MS.)


In any case, the Committee for Medicinal Products for Human Use gave Plegridy a positive recommendation, Biogen Idec said in a Friday press release. The committee, known as CHMP, advises the European Medicines Agency, the European Union’s regulatory equivalent of the US Food and Drug Administration.

Plegridy is also being reviewed by the FDA, and the hope is that it could be on the market in the US and in some European countries by the end of the year.

“The CHMP’s positive opinion for Plegridy marks an important milestone in bringing a meaningful treatment advance to people with MS in the EU,”  Douglas E. Williams, a Biogen Idec executive vice president, said in a statement. “We believe Plegridy will offer physicians and those living with MS a unique treatment option that combines efficacy, a favorable safety profile consistent with the established interferon class, and a once-every-two-week dosing schedule.”

Chris Reidy can be reached at
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