A diabetes drug that GlaxoSmithKline (NYSE submitted for regulatory approval has been pushed back three months to give the Food and Drug Administration more time.
The British drug maker, which operates its U.S. headquarters in Research Triangle Park, said Friday that the date for an approval decision is now April 15, 2014. GSK gave no indication that there were any problems with its compound saying the delay is “to provide time for a full review of information submitted by GSK in response to the Food and Drug Administration’s requests.
GSK said that its albiglutide application with the European Medicines Agency, which was filed on March 7, is on schedule.
Albiglutide is a biological, injectable form of human GLP-1, a peptide that helps the body maintain normal blood-sugar levels and also helps control appetite. People who have type 2 diabetes experience reduced GLP-1 secretion in response to a meal. Albiglutide fuses human GLP-1 to human albumin, which is intended to potentially extend the duration of the drug. That means patients would need less frequent injections. Albiglutide was studied as a once-weekly injectable.
If approved, albiglutide would compete against Novo Nordisk’s blockbuster diabetes drug Victoza, a daily injectable, among other diabetes drugs. In recent tests against other diabetes treatments, albiglutide has had mixed results.