Gattex Goes To Advisory Panel With Positive Confirmatory Trial Data

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...

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