GSK diabetes drug albiglutide gets FDA approval

British drugmaker GlaxoSmithKline has been given the go ahead to launch its once-weekly diabetes treatment albiglutide in America.
The medication, which only recently gained European approval, has received a green light from the U.S. Food and Drug Administration (FDA) for treatment of type 2 diabetes, although GSK said it doesn’t plan to launch the product until the third quarter.
The FDA approval is for improving blood glucose control, along with diet and exercise, in adult patients with type 2 diabetes, either on its own (monotherapy) or as a combination therapy with other glucose-lowering medicines including insulin.
Sold in Europe as Eperza, albiglutide will be marketed under the brand name Tanzeum in the U.S. where it will go up against other GLP-1 agonists (incretin mimetics) including AstraZeneca’s Byetta and Bydureon (exenatide), and Novo Nordisk’s market leader Victoza (liraglutide).
As well as competing with these three drugs, albiglutide could also face stiff competition from Lilly’s once-weekly product dulaglutide, which is currently under FDA review and could approved later this year, and Novo Nordisk’s long-acting semaglutide which is now in late-stage testing.