GSK diabetes drug set for European approval
LONDON (Reuters) - GlaxoSmithKline said on Friday European regulators had given the green light to its once-weekly diabetes drug albiglutide, which it is marketing as Eperzan.
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 authorization 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 their condition.
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 Lilly's dulaglutide.
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.