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You are here: Home / Health / EMA gives nod to GlaxoSmithKline’s diabetes drug Eperzan, final decision soon

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

January 27, 2014 Posted by Contributor

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.

 

 

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Filed Under: Health Tagged With: Eperzan, Eperzanin Europe, GlaxoSmithKline

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