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GSK submits albiglutide BLA to FDA for T2D

Monday, January 14, 2013 02:20 PM

GlaxoSmithKline (GSK), a global research-based pharmaceutical and healthcare company, announced a regulatory submission to the FDA for albiglutide, an investigational once-weekly treatment for adult patients with type 2 diabetes. 

Albiglutide, a GLP-1 receptor agonist, is an investigational biological product for the treatment of type 2 diabetes. 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.

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 E.U. as well in early 2013.

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