Regulatory update – GSK announces submission of albiglutide BLA to the US FDA for the treatment of type 2 diabetes

GlaxoSmithKline (GSK) plc today announced a regulatory submission to the US Food and Drug Administration (US FDA) for albiglutide, an investigational once-weekly treatment for adult patients with type 2 diabetes. Albiglutide is not yet approved as a treatment for type 2 diabetes or any other indication anywhere in the world. GSK intends to submit a regulatory application in the European Union (EU) in early 2013.

About albiglutide

Albiglutide, a GLP-1 receptor agonist, is an investigational biological product for the treatment of type 2 diabetes designed for once-weekly subcutaneous dosing. GLP-1 is a peptide that is normally secreted from the gastrointestinal tract during a meal which 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. GLP-1 is rapidly degraded while 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.