CHMP recommends Eperzan(albiglutide) for Type 2 Diabetes-GSK

GlaxoSmithKline announced that on 24 January 2014 the 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. The CHMP opinion concerns albiglutide proposed as a once-weekly treatment to improve glycaemic control in adult patients with type 2 diabetes mellitus: -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 intolerance -As 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 US Food and Drug Administration (FDA) and the US Prescription Drug User Fee Act (PDUFA) target date is 15 April 2014. Albiglutide is not approved for use anywhere in the world.