GlaxoSmithKline’s Diabetes Drug Moves Toward European Approval
GlaxoSmithKline (NYSE:GSK) announced Friday that it has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use regarding the company’s type 2 diabetes treatment, albiglutide, under the brand name Eperzan. The committee recommended marketing authorization for the drug as “a once-weekly treatment to improve glycaemic control in adult patients,” according to a GlaxoSmithKline press release on Friday.
The EMA said that albiglutide is approved as an add-on therapy in patients for whom other glycaemic-lowering medicines aren’t providing adequate glycaemic control, and was also approved use as a monotherapy in patients for whom the widely-used metformin isn’t appropriate due to intolerance or contraindications, according to Reuters.
“Today’s positive opinion is a major milestone towards offering people with uncontrolled type 2 diabetes a new option to help manage their condition and we look forward to the final decision of the European Commission in the coming months,” said Dr. Carlo Russo, Senior Vice President of Research and Development at GSK. The company expects a final decision from the European agency later this quarter.