As expected, regulators in Europe have given the green light to GlaxoSmithKline once-weekly diabetes drug Eperzan.
After its Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion in January, the European Medicines Agency has approved Eperzan (albiglutide) as monotherapy in patients for whom metformin is considered inappropriate and as an add-on combination. It is glucagon-like peptide-1 (GLP-1) receptor agonist, administered once-weekly using an injector pen.
The authorisation of albiglutide is principally based on eight Phase III studies involving over 5,000 patients and evaluating Eperzan against commonly-used classes of type 2 diabetes treatment, including insulin. GSK noted that while many diabetes registration trials are just six months in duration, five of its late-stage studies included patient follow-up for up to three years.
Eperzan will be launched in several countries in Europe in the third and fourth quarters. The US Food and Drug Administration is due to deliver its verdict on the drug by April 15.
The GLP-1 market is a competitive one, 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. Also showing promise in late-stage studies is Eli Lilly’s dulaglutide.
