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...