GlaxoSmithKline could soon have its first approval for its once-weekly diabetes drug Eperzan (albiglutide), which belongs to the class of injectable medications known as glucagon-like peptide-1 (GLP-1) receptor agonists.
The British pharmaceutical company’s new type 2 diabetes therapy was recently given a positive recommendation by advisors to the European Medicines Agency (EMA), a step which is usually followed by marketing authorisation by the European Commission.
The recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) concerns Eperzan proposed as both:
monotherapy, when diet and exercise alone do not provide adequate blood glucose control in adult type 2 diabetes patients for whom metformin treatment is considered inappropriate, and:
add-on therapy, in combination with other glucose-lowering products including basal insulin, when these, together with diet and exercise, do not provide adequate glucose control.
Carlo Russo, GSK’s senior vice president for R&D, said: “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.
“Diabetes is a global health problem, affecting over 300 million people worldwide. Albiglutide has the potential to help many patients with type 2 diabetes who struggle to control their blood glucose levels.”
GlaxoSmithKline said the CHMP positive opinion recommending Eperzan’s marketing authorisation is based on the results of clinical studies involving over 5,000 diabetic patients.
The GLP-1 agonist achieved its main goals in 5 of the studies reported last year, but failed to show the same effectiveness as the type 2 diabetes drug pioglitazone (Actos).