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Glaxosmithkline Plc Announces Submission Of Albiglutide BLA To USFDA For Treatment Of Type 2 Diabetes


Monday, 14 Jan 2013 05:00am EST 

Glaxosmithkline Plc 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. 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. 

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18.41
0.17 +0.93%
26 Aug 2014