Short Bowel Syndrome Drug Receives FDA Drug Advisory Committee Recommendation

Gattex (teduglutide), a drug for the treatment of adult short bowel syndrome, has received a recommendation for approval from the FDA’s Gastrointestinal Drugs Advisory Committee, according to a news release.

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The drug is developed by NPS Pharmaceuticals.

 

If approved, Gattex would be the first FDA-approved therapy indicated for the long-term treatment of adults with short bowl syndrome, according to the release. The disorder prevents the body from absorbing enough nutrients and fluids through the gastrointestinal track.

 

The Prescription Drug User Fee Act date for FDA’s completion of review of the new drug application for Gattex is December 30.

 

NPS Pharmaceuticals is headquartered in Bedminster, N.J.

 

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