GSK officials said the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending marketing authorization for albiglutide, under the brand name Eperzan.
The committee's opinion concerns albiglutide proposed as a once-weekly treatment to improve glycemic control in adult patients with type 2 diabetes mellitus:
-- As monotherapy, when diet and exercise alone do not provide adequate glycemic 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 glycemic control.
"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," Dr. Carlo Russo, senior vice president for research and development at GSK, said in a statement.
"Albiglutide has the potential to help many patients with type 2 diabetes who struggle to control their blood glucose levels."
The opinion is based on an evaluation of a comprehensive global program of studies involving more than 5,000 patients, which 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.
Albiglutide is currently undergoing review by the U.S. Food and Drug Administration, GSK said. Albiglutide is not approved for use anywhere in the world.
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