EU approves GSK's once-weekly diabetes drug Eperzan
GlaxoSmithKline plc today announced that the European Commission has granted marketing authorization for its once-weekly diabetes treatment, Eperzan® (albiglutide). Eperzan is indicated for the treatment of type 2 diabetes mellitus in adults, to improve glucose control.
Albiglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is a biological product for the treatment of type 2 diabetes, administered once-weekly using an injector pen and supplied with a short (5mm) thin-wall needle. GLP-1 is an important incretin hormone that helps normalize blood glucose levels but, in people with type 2 diabetes, its production is reduced or absent.
The EMA authorization of albiglutide is based on the results of the comprehensive Harmony programme, comprising eight Phase III studies. The Harmony programme involved over 5,000 patients and evaluated albiglutide against commonly-used classes of type 2 diabetes treatment, including insulin, in patients at different stages of the disease, as well as those with renal impairment. While many diabetes registration trials are just six months in duration, five of the Harmony trials included patient follow-up for up to three years.
GSK expects to launch albiglutide in several countries in Europe in Q3-4 2014 with additional launches to follow thereafter.
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.
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