FDA pushes back advisory meeting for Liraglutide to April 2009

11/26/2008

BAGSVAERD, Denmark The Food and Drug Administration has informed Novo Nordisk that it has rescheduled the Advisory Committee meeting for Liraglutide, the Danish drug maker announced last week.

The FDA had originally scheduled the meeting to take place on March 2, but it has been moved to April 2 or 3.

The company submitted an approval application for Liraglutide, a treatment for diabetes, on May 23, meaning that it can expect an action letter from the FDA by March 23, following a standard 10-month review period.

Liraglutide is a once-daily, human glucagon-like peptide-1 analogue that the company has developed as a treatment for Type 2 diabetes. It works by inhibiting appetite and by stimulating the release of insulin only when glucose levels become too high.

X
This ad will auto-close in 10 seconds