GSK seeks FDA approval for new GLP-1 agonist

British healthcare firm GlaxoSmithKline has filed for US regulatory approval of its new type 2 diabetes drug albiglutide, which belongs to the same group of injectable GLP-1 receptor agonists as Byetta, Bydureon and Victoza .
GSK announced on Monday that it had submitted the once-weekly medication to the US Food and Drug Administration (FDA) for approval and confirmed that it also plans to seek European Union regulatory approval for the new product in 2013.
Albiglutide is one of a number of new drugs developed by GSK that it hopes will boost its product portfolio, but it is yet to be approved as a treatment for type 2 diabetes or any other indication anywhere in the world.
Results from GSK’s Phase III 52-week Harmony 8 study of the drug, released last year, showed that after 26-weeks albiglutide was more effective than Merck and Co’s DPP-4 inhibitor Januvia (sitagliptin) at reducing HbA1c levels in patients with type 2 diabetes and kidney impairment.
However, it was also announced that albiglutide failed to match Novo Nordisk’s Victoza for lowering HbA1c and reducing body weight.
GLP-1 (glucagon-like peptide-1) is an incretin that is normally secreted from the gastrointestinal tract during a meal, which in turn promotes the release of insulin to control post-meal rises in blood sugar levels. But in people with type 2 diabetes, GLP-1 secretion in response to a meal is either reduced or non-existent.
GLP-1 agonists such as albiglutide work by helping the body release more insulin after eating.