<em>Gattex</em> Goes To Advisory Panel With Positive Confirmatory Trial Data

Gattex Goes To Advisory Panel With Positive Confirmatory Trial Data

22 Aug 2012

• By Cathy Dombrowski

Clinical data for teduglutide, which goes before the Gastrointestinal Drugs Advisory Committee Oct. 16 as the first drug for treating short bowel syndrome, includes positive results from a confirmatory trial and mixed results from the initial study.

FDA will take the first pharmaceutical therapy for short bowel syndrome – NPS Pharmaceuticals Inc.’s Gattex (teduglutide) – to an Oct. 16 Gastrointestinal Drugs Advisory Committee where panel members will balance mixed results from an initial study with positive findings from a confirmatory trial.

Teduglutide, which has orphan drug status, has had a long road to regulatory review. FDA requested the second study in...