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Diabetes Drug Albiglutide Submitted for FDA Review
Albiglutide (GlaxoSmithKline) — an investigational once-weekly treatment for adults with type 2 diabetes — has been submitted to the FDA for review.
Albiglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is a 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.
Albiglutide consists of two copies of modified human GLP-1 fused in series to human albumin and is designed to have a longer duration of action than endogenous GLP-1.
Last year, positive results were reported from the Harmony 8 phase III trial, in which albiglutide was compared with a dipeptidyl peptidase-4 (DPP-4) inhibitor, sitagliptin (Januvia, Merck Sharpe & Dohme), in 507 patients with type 2 diabetes and renal impairment.
At the 26-week primary endpoint, albiglutide showed clinically and statistically significant reductions in hemoglobin A1c from baseline (8.08% for albiglutide vs. 8.22% for sitagliptin) and superiority versus sitagliptin (reduction of –0.83% vs. –0.52%, respectively; P P = 0.0003 for superiority). At the primary endpoint, weight loss was significantly greater in the albiglutide group than in the sitagliptin group (–0.79 kg vs. –0.19 kg, respectively; P = 0.0281).