Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The European Commission (EC) has granted marketing authorization for GlaxoSmithKline's (GSK's) once-weekly diabetes treatment, Eperzan (albiglutide).
Subscribe to our email newsletter
The drug is indicated for the treatment of type 2 diabetes mellitus in adults, to improve glucose control 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.
Eperzan 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.
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 an important incretin hormone that helps normalise blood glucose levels but, in people with type 2 diabetes, its production is reduced or absent.
The drug is administered once-weekly using an injector pen and supplied with a short (5mm) thin-wall needle.
The approval is based on the results of the comprehensive Harmony program, which includes eight Phase III studies.
The Harmony program involved over 5,000 patients and assessed 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 plans to launch albiglutide in several countries in Europe in the third or fourth quarter of 2014 with additional launches to follow thereafter.
Image: GlaxoSmithKline headquaters in Brentford, London, England. Photo: courtesy of Maxwell Hamilton