FDA updates on delay for Nordisk's liraglutide

The US Food and Drug Administration has delayed its scheduled Advisory Committee meeting with Novo Nordisk for liraglutide until April 2009.

The firm submitted the liraglutide New Drug Application in May, with an action letter expected in March 2009. In September, the agency told Nordisk that it would most likely have to extend the date of completing its assessment by a couple of months and now says this is still the timeline it is targeting.

Once-daily liraglutide is a human glucagon-Like Peptide-1 analog developed for the treatment of type 2 diabetes. It works by stimulating the release of insulin only when glucose levels become too high and by inhibiting appetite.