GlaxoSmithKline has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for albiglutide, under the brand name Eperzan, for treatment of type 2 diabetes.
A glucagon-like peptide-1 (GLP-1) receptor agonist, Albiglutide is indicated as a once-weekly treatment to improve glycaemic control in adult patients with type 2 diabetes.
GSK senior vice-president of research and development Carlo Russo said: "Albiglutide has the potential to help many patients with type 2 diabetes who struggle to control their blood glucose levels."
The positive opinion is based on an assessment of a global programme of studies involving more than 5,000 patients, which included eight Phase III trials assessing albiglutide against commonly used classes of type 2 diabetes treatment and involved patients at different stages of the disease, as well as those with renal impairment, for up to three years.
A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission and GSK expects a final decision on the drug during the first quarter of 2014.
Albiglutide is also currently undergoing review by other agencies, including the US Food and Drug Administration (FDA) and the US Prescription Drug User Fee Act (PDUFA) is 15 April 2014.
Albiglutide can be used as a 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, as well as 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.
According to the company, albiglutide is currently not approved for use anywhere in the world.
Image: Action of GLP-1 and DPP-4 inhibitors. Photo: courtesy of Ilmari Karonen.