GSK receives European authorisation for once-weekly type 2 diabetes treatment, Eperzan®

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the European Commission has granted marketing authorisation 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 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 intolerance¹
• 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.¹

Vlad Hogenhuis, Senior Vice-President and Head, GSK Global Cardiovascular, Metabolic and Neurosciences (CVM&NS) Franchise, 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.^2,3 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.”^1,4

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 normalise blood glucose levels but, in people with type 2 diabetes, its production is reduced or absent.

The EMA authorisation 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.

References

1. Eperzan EU Summary of Product Characteristics.
2. Ali MK, et al. Achievement of goals in US diabetes care. 1999-2010. N Engl J Med. 2013;368:1613-1624.
3. Fu AZ, Qiu Y, Radican L, Yin DD, Mavros P. Pre-existing cardiovascular diseases and glycemic control in patients with type 2 diabetes mellitus in Europe: a matched cohort study. Cardiovasc Diabetol. 2010 Apr 21; 9:15.
4. Eperzan European Public Assessment Report.