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Glaxosmithkline Plc receives positive opinion from the CHMP in Europe for once-weekly EperzanTM (Albiglutide) for the treatment of type 2 diabetes


Friday, 24 Jan 2014 05:41am EST 

Glaxosmithkline Plc:Says Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for albiglutide, under the brand name Eperzan.Says CHMP opinion concerns albiglutide proposed as a once-weekly treatment to improve glycaemic control in adult patients with type 2 diabetes mellitus.Says CHMP positive opinion is one of the last steps before marketing authorisation is granted by the European Commission.Says final decision on marketing authorisation is anticipated during the Q1 of 2014.Says Albiglutide is currently undergoing review by other authorities, including the US Food and Drug Administration (FDA) and the US Prescription Drug User Fee Act (PDUFA) target date is Apr. 15. 

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