LONDON, Jan 24 (Reuters) - GlaxoSmithKline said onFriday European regulators had given the green light to itsonce-weekly diabetes drug albiglutide, which it is marketing asEperzan.
Albiglutide belongs to the same class of injectable GLP-1drugs as Victoza from Novo Nordisk, as well as Byettaand Bydureon from Bristol-Myers Squibb and AstraZeneca.
A positive recommendation for a drug by the EuropeanMedicines Agency (EMA) is generally followed by a marketingauthorisation by the European Commission. GlaxoSmithKline (GSK)said a final decision was anticipated later this quarter.
Albiglutide has been approved for patients for whom thewidely-used metformin is considered inappropriate, and as anadd-on therapy when other glucose-lowering products do notprovide adequate glycaemic control, the EMA said.
Carlo Russo, GSK's senior vice president for R&D, said therecommendation was a major milestone towards offering peoplewith uncontrolled type 2 diabetes a new option to help managetheir condition.
The drug met its main goal in five studies reported lastyear, but it did not demonstrate it was equally as good aspioglitazone, an existing diabetes treatment.
Industry analysts therefore have said it may struggleagainst competitors, and new drugs in development, such as EliLilly's dulaglutide.
The consensus forecast for albiglutide currently points tomodest annual sales of about $400 million by 2018, according toa Thomson Reuters Pharma survey of six analysts.
Last year regulators in the United States pushed back anapproval decision on the drug until April 15.
Astrazeneca (AZN)
Glaxosmithkline (GSK)
