GlaxoSmithKline (NYSE:GSK) announced Friday that it has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use regarding the company’s type 2 diabetes treatment, albiglutide, under the brand name Eperzan. The committee recommended marketing authorization for the drug as “a once-weekly treatment to improve glycaemic control in adult patients,” according to a GlaxoSmithKline press release on Friday.
The EMA said that albiglutide is approved as an add-on therapy in patients for whom other glycaemic-lowering medicines aren’t providing adequate glycaemic control, and was also approved use as a monotherapy in patients for whom the widely-used metformin isn’t appropriate due to intolerance or contraindications, according to Reuters.
“Today’s positive opinion is a major milestone towards offering people with uncontrolled type 2 diabetes a new option to help manage their condition and we look forward to the final decision of the European Commission in the coming months,” said Dr. Carlo Russo, Senior Vice President of Research and Development at GSK. The company expects a final decision from the European agency later this quarter.
The announcement is a huge step forward for the drug, which previously had been met with skepticism after it failed to demonstrate efficacy on par with pioglitazone, an already existing diabetes medicine. The drug is also under review by regulators in the U.S., who pushed back the approval decision date for the drug to April 15. Many analysts have since speculated that the drug may struggle amongst competitors as well as similar drugs that are still under development, namely Eli Lilly’s dulaglutide.
A Reuters survey of six analysts indicates that GSK’s albiglutide can expect modest annual sales of about $400 million by 2018. Albiglutide belongs to the same class of drugs as other injectable GLP-1 treatments such as Byetta and Bydureon from Bristol-Myers Squibb and AstraZeneca, as well as Victoza from Novo Nordisk.