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GSK submits albiglutide for European approval

If approved the diabetes drug will be launched as Eperzan

GSK - logo on buildingGlaxoSmithKline (GSK) has submitted its albiglutide once-weekly injection for type 2 diabetes to European regulators.

If approved the biologic treatment, which was submitted for US approval in January, will be marketed as Eperzan.

Albiglutide is, along with lupus treatment Benlysta and heart disease drug darapladib, one of a trio of drugs GSK has developed with Human Genome Sciences.

The diabetes treatment is a receptor agonist of the GLP-1 peptide, which is normally secreted from the gastrointestinal tract during a meal and in turn helps release insulin to control blood sugar elevations after eating. 

In people with type 2 diabetes, GLP-1 secretion in response to a meal is reduced or absent and GSK said albiglutide has been developed to have a longer duration of action by being comprised of two copies of modified human GLP-1 fused in series to human albumin.

The diabetes treatment is in the same class as two established GLP-1 receptor agonists, Novo Nordisk's Victoza (liraglutide) and Lilly's Byetta (exenatide).

Albiglutide's phase III's trial programme, known as Harmony, includes studies that compare the drug's safety and efficacy to that of Victoza and Merck & Co's DPP-4 inhibitor Januvia (sitagliptin).

But the trial comparing GSK's drug with Victoza, the results of which were released in November 2011, failed to show that albiglutide was not inferior to Novo's rival drug.

GSK subsequently said that seven of the eight Harmony studies showed positive results and the company will be hoping that albiglutide's more favourable dosing regimen will give it an edge over its more established rivals.

8th March 2013

From: Sales

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