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Home Industry News Biogen receives CHMP backing for multiple sclerosis drug Zinbryta

Biogen receives CHMP backing for multiple sclerosis drug Zinbryta

4th May 2016

Biogen has announced that its multiple sclerosis drug Zinbryta has been recommended for European approval by the Committee for Medicinal Products for Human Use (CHMP).

The European Medicines Agency committee has issued a positive opinion on the approval of the drug for the treatment of relapsing forms of multiple sclerosis. The once-monthly, self-administered, subcutaneous therapy was developed alongside AbbVie.

In two clinical trials, DECIDE and SELECT, it was shown that the drug was able to reduce annualised relapse rates associated with the disease, as well as the risk of 24-week confirmed disability progression.

Zinbryta is also currently under regulatory review in the US, Switzerland, Canada and Australia.

Dr Alfred Sandrock, executive vice president and chief medical officer at Biogen, said: "Zinbryta may offer another option for people with multiple sclerosis with its targeted mechanism of action, which did not cause broad and prolonged immune cell depletion."

The CHMP also recently recommended Biogen's Flixabi, a new biosimilar based on Remicade, for European approval.ADNFCR-8000103-ID-801817788-ADNFCR

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