EU approves once-weekly diabetes treatment, Eperzan
GlaxoSmithKline plc announced that the European Commission has granted marketing authorisation for its once-weekly diabetes treatment, Eperzan (albiglutide). Eperzan is indicated for the treatment of Type 2 Diabetes Mellitus in adults, to improve glucose control as:
-Monotherapy, when diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to contraindications or intolerance1
-Add-on combination therapy, in combination with other glucose-lowering medicinal products, including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
Albiglutide is currently undergoing review by other authorities, including the FDA and the US Prescription Drug User Fee Act (PDUFA) target date is 15 April 2014.
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