(Reuters) - GlaxoSmithKline Plc said on Wednesday that it had received European marketing approval for its once-weekly diabetes drug albiglutide, which it is marketing as Eperzan.
The drug received a positive recommendation from the European Medicines Agency (EMA) in January.
GSK said it expects to launch albiglutide in several countries in Europe in the third to fourth quarter this year.
Albiglutide is currently under review by the US Food and Drug Administration (FDA), which is expected to give its opinion on the drug by April 15.
The EMA authorization of albiglutide was based on the results of the Harmony program comprising eight late stage studies, the company said.
The Harmony program involved over 5,000 patients and evaluated albiglutide against commonly-used classes of type 2 diabetes treatment, including insulin, in patients at different stages of the disease, as well as those with renal impairment.
Shares in GSK were trading up 0.2 percent at 1625.8 pence per share at 1336 GMT on the London Stock Exchange.
(Reporting by Roshni Menon in Bangalore; Editing by Mathew Veedon)
- Pharmaceuticals & Drug Trials
- European Medicines Agency
- GlaxoSmithKline Plc