UK drug giant GlaxoSmithKline is planning to file for approval of albiglutide as a diabetes treatment early next year, after the drug turned in a solid performance in its Phase III clinical trial programme.
The company said it now has data from the Phase III Harmony 8 trial as well as an event driven meta-analysis assessing the cardiovascular safety of albiglutide across the whole clinical programme, thereby completing the package of data needed for its registration.
The 52-week Harmony 8 study compared the GLP-1 agonist albiglutide with Merck & Co's DPP-4 inhibitor Januvia (sitagliptin) in 507 patients with diabetes type 2 and renal impairment.
After 26-weeks, albiglutide 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.
In addition, weight loss was significantly greater in the albiglutide group than the sitagliptin treatment arm, with reductions of 0.79kg and 0.19kg, respectively.
In more good news, GSK said its drug, which is being developed as once-weekly injection using a pen injector, was generally well tolerated over the treatment period, with diarrhoea being the most common side effect for albiglutide (10%) versus Januvia (6.5%).
With regard to the meta-analysis, data from all eight Phase III Harmony studies involving around 5,000 patients and from one Phase II study were included, and revealed no excess cardiovascular risk, the group noted.
Available by 2014?
On the back of these results, GSK said it ends to kick off regulatory submissions in early 2013, which means that, all things going well, albiglutide could be on the market by 2014, where it will compete with Novo Nordisk's Victoza and Amylin Pharmaceuticals' Byetta and Bydureon, in addition to others potentially coming through the pipeline.
According to a forecast compiled by Thomson Reuters Pharma, analysts are expecting the drug to pull in sales of around $285 million a year by 2016.
Albiglutide is one of three products developed with partner Human Genome Sciences, with which GSK is currently embroiled in a hostile takeover battle, having recently extended its offer of $13 a share, or $2.6 billion, until July 20.