The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorization for GlaxoSmithKline’s type 2 diabetes therapy albiglutide, under the brand name EperzanTM.
Albiglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is an investigational biological product for the treatment of type 2 diabetes, designed for once-weekly subcutaneous dosing.
The CHMP opinion concerns albiglutide proposed as a once-weekly treatment to improve glycemic control in adult patients with type 2 diabetes both as a monotherapy, when diet and exercise alone do not provide adequate glycemic control in patients for whom the use of metformin is considered inappropriate due to contraindications or intolerance, and as a add-on combination therapy, in combination with other glucose-lowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide adequate glycemic control.
The CHMP positive opinion is based on an evaluation of a comprehensive global program of studies involving over 5,000 patients. The program included eight Phase III trials evaluating albiglutide against commonly-used classes of type 2 diabetes treatment and involved patients at different stages of the disease, as well as those with renal impairment, for up to three years.
A CHMP positive opinion is one of the last steps before marketing authorization is granted by the European Commission. A final decision on marketing authorization is anticipated during the first quarter of 2014.
Albiglutide is currently undergoing review by other authorities, including the US Food and Drug Administration (FDA) and the US Prescription Drug User Fee Act (PDUFA) target date is 15 April 2014. Albiglutide is not approved for use anywhere in the world.