LONDON Jan 24 GlaxoSmithKline said on
Friday European regulators had given the green light to its
once-weekly diabetes drug albiglutide, which it is marketing as
Albiglutide belongs to the same class of injectable GLP-1
drugs as Victoza from Novo Nordisk, as well as Byetta
and Bydureon from Bristol-Myers Squibb and AstraZeneca
A positive recommendation for a drug by the European
Medicines Agency (EMA) is generally followed by a marketing
authorisation by the European Commission. GlaxoSmithKline (GSK)
said a final decision was anticipated later this quarter.
Albiglutide has been approved for patients for whom the
widely-used metformin is considered inappropriate, and as an
add-on therapy when other glucose-lowering products do not
provide adequate glycaemic control, the EMA said.
Carlo Russo, GSK's senior vice president for R&D, said the
recommendation was a major milestone towards offering people
with uncontrolled type 2 diabetes a new option to help manage
The drug met its main goal in five studies reported last
year, but it did not demonstrate it was equally as good as
pioglitazone, an existing diabetes treatment.
Industry analysts therefore have said it may struggle
against competitors, and new drugs in development, such as Eli
The consensus forecast for albiglutide currently points to
modest annual sales of about $400 million by 2018, according to
a Thomson Reuters Pharma survey of six analysts.
Last year regulators in the United States pushed back an
approval decision on the drug until April 15.