(By Balaseshan) GlaxoSmithKline Plc (NYSE: GSK), a manufacturer of pharmaceutical products, said it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for albiglutide to treat type 2 diabetes.
GlaxoSmithKline said it intends to submit a regulatory application in the European Union (EU) in early 2013, as the drug is not yet approved to treat type 2 diabetes or any other indication anywhere in the world.
Albiglutide, a GLP-1 receptor agonist, is an investigational biological product for the treatment of type 2 diabetes designed for once-weekly subcutaneous dosing.
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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.
GSK is engaged in the creation and discovery, development, manufacture and marketing of pharmaceutical products, including vaccines, over-the-counter (OTC) medicines and health-related consumer products. It operates in three primary areas of business: Pharmaceuticals, Vaccines and Consumer Healthcare.
GSK closed Friday's regular session up 0.11% at $44.54. The stock has been trading between $41.68 and $47.69 for the past 52 weeks.