March 26 GlaxoSmithKline Plc said on
Wednesday that it had received European marketing approval for
its once-weekly diabetes drug albiglutide, which it is marketing
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 authorisation of albiglutide was based on the
results of the Harmony programme comprising eight late stage
studies, the company said.
The Harmony programme 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