Advisors to the European Medicines Agency have recommended approval of GlaxoSmithKline's once-weekly diabetes drug Eperzan.
The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Eperzan (albiglutide). The drug is a glucagon-like peptide-1 (GLP-1) receptor agonist and final approval is expected later in the quarter.
The CHMP backing is based on a programme including eight Phase III trials involving over 5,000 patients. Albiglutide will the crowded GLP-1 marketplace which is dominated by Novo Nordisk's once-a-day Victoza (liraglutide), AstraZeneca's twice-daily Byetta (exenatide) and an extended-release formulation of the latter, Bydureon.
Last August, the US Food and Drug Administration extended its review on Eperzan and the drug now has a Prescription Drug User Fee Act (PDUFA) date of April 15.
More CHMP opinions will be published later today.