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Hepatic Safety Of Biogen Idec’s Zinbryta Under Close Scrutiny In EU

 
• By Ian Schofield

The EU review of Biogen Idec’s MS drug Zinbryta is continuing as a special group at the European Medicines Agency prepares to discuss a list of questions regarding the product’s hepatic safety profile. The EMA has until the end of November to give its views on the product’s future.

Side effects
The EMA is reviewing the hepatic side-effects of MS drug Zinbryta

Biogen Idec’s injectable multiple sclerosis drug, Zinbryta (daclizumab), is coming under scrutiny this week as the European Medicines Agency continues its review of the product’s safety profile following reports of serious hepatic adverse reactions including the death of a patient from fulminant liver failure.

The review is being conducted by the EMA’s Pharmacovigilance Risk Assessment Committee under an Article 20 referral initiated in summer...

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