GSK Receives European Approval for Diabetes Drug Eperzan

By Pharma News - DCAT Publisher

March 26, 2014

GlaxoSmithKline (GSK) has been granted marketing authorization by the European Commission 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 a 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, and as an 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, a glucagon-like peptide-1 (GLP-1) receptor agonist, is a biological product for the treatment of Type 2 diabetes, administered once-weekly using an injector pen and supplied with a short (5 mm) thin-wall needle. GLP-1 is an important incretin hormone that helps normalize blood glucose levels but, in people with Type 2 diabetes, its production is reduced or absent. 

GSK expects to launch albiglutide in several countries in Europe in the third quarter 2014  with additional launches to follow thereafter.

Albiglutide is currently undergoing review by other regulatory authorities, including FDA.  

Source: GlaxoSmithKline