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March 26, 2014

European Commission approves GSK’s diabetes drug Eperzan

The European Commission (EC) has granted marketing approval for GlaxoSmithKline's (GSK's) once-weekly diabetes drug albiglutide, which is marketed as Eperzan.

The European Commission (EC) has granted marketing approval for GlaxoSmithKline’s (GSK’s) once-weekly diabetes drug albiglutide, which is marketed as Eperzan.

The drug is indicated for treatment of type 2 diabetes mellitus in adults to improve glucose control.

GSK said that the drug is used as monotherapy, when diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to contraindications or intolerance.

The drug is also used as an 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 glycaemic control.

"The authorisation of albiglutide means that healthcare professionals and patients will have access to a new once-weekly treatment option that has shown effective blood glucose lowering with durable control and is generally well-tolerated."

GSK senior vice-president and head of global cardiovascular, metabolic and neurosciences (CVM&NS) Franchise Vlad Hogenhuis said diabetes treatment can be challenging for healthcare professionals and patients, often involving complex daily regimens, with almost 50% of patients failing to meet their blood glucose targets.

"The authorisation of albiglutide means that healthcare professionals and patients will have access to a new once-weekly treatment option that has shown effective blood glucose lowering with durable control and is generally well-tolerated," Hogenhuis said.

Albiglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is a major incretin hormone that helps normalise blood glucose levels but, in people with type 2 diabetes, its production is reduced or lacking.

The once-weekly drug is administered using an injector pen and supplied with a short (5mm) thin-wall needle.

European approval is based on the results of the Harmony programme, which includes eight Phase III trials involving over 5,000 patients.

The programme 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.

GSK intends to launch albiglutide in several countries in Europe in the third or fourth quarter of 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.

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