GlaxoSmithKline has been given a green light to launch its once-weekly diabetes drug albiglutide in the US, shortly after gaining approval for the GLP-1 agonist in Europe.
Albiglutide has been approved by the FDA under the Tanzeum brand name and will compete in the US market with Novo Nordisk’s Victoza (liraglutide) and AstraZeneca’s Byetta (exenatide) – both given daily – as well as AZ’s once-weekly line extension Bydureon.
Albiglutide – which will be sold in Europe as Eperzan – has been approved for improving glycaemic control along with diet and exercise, and can be used alone or in combination with other glucose-lowering drugs including insulin. GSK – which has been seeking a partner to help it market albiglutide for some time, says it intends to launch the drug in the US in the third quarter.
Victoza is the undisputed leader in the GLP-1 agonist category with sales of more than $2bn last year, despite coming to market some years after Byetta and its less favourable dosing frequency compared to Bydureon.
AZ’s drugs brought in $357m in 2013, with the advantages of Bydureon’s less frequent dosing offset by a large needle that has reduced its popularity with patients. The company has said it expects to grow sales after taking control of the franchise from former partner Bristol-Myers Squibb (BMS) and launching a new pen injector version of Bydureon.
Meanwhile, GSK could face near-term competition from Lilly, whose once-weekly dulaglutide is currently under FDA review, as well as Novo Nordisk’s long-acting semaglutide which is in late-stage testing.
Given the fairly crowded market analyst predictions for albiglutide sales have been fairly modest at around $400m-$500m a year. One factor that could hold back uptake of albiglutide are the results of studies which showed it was not as effective as pioglitazone in controlling blood sugar, as well as mixed results in trials comparing it with Victoza.
Nevertheless the approval is a piece of good news for GSK, which has seen a series of knockbacks in its pipeline in recent weeks.
Earlier this month the company stopped a late-stage trial of its investigational cancer vaccine MAGE-A3 in lung cancer, while in March it withdrew a marketing application in the EU for its ovarian cancer therapy Votrient (pazopanib).