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.