GlaxoSmithKline has submitted an application US regulators seeking approval to market its investigational GLP-1 receptor agonist albiglutide for the treatment of adults with type II diabetes.
The move was expected after the firm said in July last year that it had gathered enough Phase III data for global regulatory submissions in 2013, and as such it also confirmed that a filing in Europe is targeted for early this year.
As part of this clinical trial programme, the 52-week Harmony 8 study assessed albiglutide against Merck & Co's DPP-4 inhibitor Januvia (sitagliptin) in 507 patients with diabetes type 2 and renal impairment.
After 26-weeks, GSK's drug showed clinically and statistically significant reductions in HbA1c from baseline (8.08% for albiglutide and 8.22% for sitagliptin) and superiority versus sitagliptin (reduction of 0.83% vs 0.52%), the firm said.
If successful, albiglutide will compete for market share with Novo Nordisk's Victoza and Amylin Pharmaceuticals' Byetta and Bydureon, as well as others emerging on the scene.
The product, which has been developed as a once-weekly subcutaneous injection, is reportedly expected to pull in annual sales of around $367 million by 2017 (according to a forecast compiled by Thomson Reuters Pharma).