GSK Files for U.S. Approval of Albiglutide for Diabetes

January 14, 2013

LONDON (Reuters) Jan 14 - GlaxoSmithKline said on Monday it had filed for U.S. approval of its new once-weekly diabetes drug albiglutide and would make a similar submission shortly in Europe as it vies for a share of a crowded market.

Albiglutide belongs to the same class of injectable glucagon-like peptide-1 (GLP-1) receptor agonists as liraglutide (Victoza, Novo Nordisk) and exenatide (Byetta) and extended release exenatide (Bydureon), from Bristol-Myers Squibb and AstraZeneca's Amylin unit.

The submission by GSK is in line with its plan to seek regulatory approval for the new product in 2013.

Albiglutide is one of a number of new drugs GSK hopes will revive its product portfolio.

It is also hoping for approval of the two lung drugs, Relvar (fluticasone/vilanterol) and Anoro (umeclidinium bromide/vilanterol); an HIV drug called dolutegravir; and two melanoma drugs dabrafenib and trametinib.

Further ahead, GSK expects to have pivotal clinical trial results on up to 14 drugs in the next two years, including two potentially important drugs for heart disease and cancer - darapladib and MAGE-A3.