GlaxoSmithKline Plc. (GSK, GSK.L) announced Friday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has issued a positive opinion recommending marketing authorisation for albiglutide, under the brand name Eperzan.
The CHMP opinion concerns albiglutide proposed as a once-weekly treatment to improve glycaemic control in adult patients with type 2 diabetes mellitus: 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; As 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.
Albiglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is an investigational once-weekly type 2 diabetes treatment. GLP-1 is an important incretin hormone that helps normalise blood sugar levels.
A CHMP positive opinion is one of the last steps before marketing authorisation is granted by the European Commission. A final decision on marketing authorisation is anticipated during the first quarter of 2014, the company said.
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. Albiglutide is not approved for use anywhere in the world.
The company stated that CHMP positive opinion is based on an evaluation of a comprehensive global programme of studies involving over 5,000 patients. The programme included eight Phase III trials evaluating 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.
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