Albiglutide: First Global Approval

• DOI: 10.1007/s40265-014-0228-2
• Publication Date: 2014-05-26T01:57:48Z
• Authors: Raewyn M. Poole; Mary L. Nowlan
• Keywords: Glucagon-Like Peptide-1 Receptor; 3. Good health; 03 medical and health sciences; 0302 clinical medicine; Diabetes Mellitus, Type 2; Glucagon-Like Peptide 1; Receptors, Glucagon; Animals; Humans; Hypoglycemic Agents; Drug Therapy, Combination; Drug Approval

Albiglutide (Eperzan® [EU]; Tanzeum™ [US]), a glucagon-like peptide 1 receptor agonist, has been developed by GlaxoSmithKline for the treatment of type 2 diabetes mellitus (T2DM). Albiglutide has received its first global approval in this indication in the EU, for use in combination with other antihyperglycaemic agents, including basal insulin, when these drugs and diet and exercise do not provide adequate glycaemic control, and as monotherapy in patients unable to take metformin due to contraindications or intolerance when diet and exercise alone do not provide adequate glycaemic control. Albiglutide has subsequently been approved for the second-line or later treatment of T2DM as an adjunct to diet and exercise in the US. This article summarizes the milestones in the development of albiglutide leading to this first approval for the treatment of T2DM.