News Feature | March 27, 2014

GSK Wins Approval For Diabetes Drug Eperzan In EU

By Estel Grace Masangkay

GlaxoSmithKline announced that it has won approval for its once-weekly diabetes treatment Eperzan (albiglutide) in Europe.

The European Commission has granted approval for Eperzan for the treatment of Type 2 diabetes mellitus in adult patients as glucose control in the following indications:

  • Monotherapy, when diet and exercise alone do not provide adequate glycemic control in patients for whom the use of metformin is considered inappropriate due to contraindications or intolerance
  • 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 glycemic control.

Albiglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist intended for the treatment of type 2 diabetes.  The drug, a biological product, is administered once-weekly using an injector pen with a short (5mm) thin-wall needle.  Patients with Type 2 diabetes have insufficient or no GLP-1 production, which is an important incretin hormone that helps regulate blood glucose levels.

Vlad Hogenhuis, Senior Vice-President and Head of GSK Global Cardiovascular, Metabolic and Neurosciences (CVM&NS) Franchise, said, “Diabetes treatment can be challenging for healthcare professionals and patients, often involving complex daily regimens, with almost 50% of patients failing to meet their blood glucose targets. The authorization of albiglutide means that healthcare professionals and patients will have access to a new once-weekly treatment option that has shown effective blood glucose lowering with durable control and is generally well tolerated.”

The approval from the EMA is based on positive data from the Harmony program made up of eight Phase III studies. Harmony evaluated albiglutide against standard type 2 diabetes treatments, including insulin, in over 5,000 patients at different stages of the disease, as well as those with renal impairment. Five of the Harmony trials included patient follow-up for up to three years.

The company said it expects to launch albiglutide in several European countries in the second half of 2014 with additional launches to follow.