EMA gives nod to GlaxoSmithKline’s diabetes drug Eperzan, final decision soon

The European Medicines Agency (EMA) has green a green signal to GlaxoSmithKline for its once-weekly diabetes drug albiglutide.

The Committee for Medicinal Products for Human Use (CHMP) of has recommended in a positive way to the drug which is marketed under the brand name Eperzan.

Albiglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is an investigational biological product that treats type 2 diabetes. It is designed for once-weekly subcutaneous dosing.

File photo of signage on the company headquarters of GlaxoSmithKline in west London

However, the GlaxoSmithKline (GSK) has said that a final decision was anticipated later this quarter.

EMA say, Albiglutide is approved for those patients who allergic to the widely-used metformin. Moreover, it is also used as an add-on therapy when other glucose-lowering products do not provide adequate glycaemic control.

The committee gave its nod following an evaluation of a comprehensive global program of studies involving over 5,000 patients.

In 2013, the regulators in the United States have deferred the approval decision on the drug till April 15.