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FDA staff says NPS Pharma's bowel drug needs no safety restrictions

Friday, 12 Oct 2012 | 9:30 AM ET

Oct 12 (Reuters) - U.S. drug reviewers found three serious concerns related to NPS Pharmaceuticals Inc's experimental drug for short bowel syndrome, but said they did not think the drug needed to be restricted for safety reasons, according to documents posted by the Food and Drug Administration on its website Friday.

NPS shares were up 13 percent at $10.30 on Friday morning on the Nasdaq.

The three risks observed by the FDA staff are gastrointestinal obstruction, biliary and pancreatic disorders and an acceleration in the growth of new tissue and colon polyps.htt p://link.reuters.com/nuq33t

The staff said that the drug's approval would warrant a risk evaluation and mitigation strategy and supported the plans proposed by the company.

However, it added that access to Gattex should not be restricted and the drug did not require any further assessment to assure safe use as it would be prescribed by skilled physicians and specialists.

The FDA review of NPS's Gattex, or teduglutide, comes ahead of an advisory meeting of independent experts next week to discuss the drug.

The FDA, which will take into account the panel's recommendations, is expected to make a final decision on the drug by Dec. 30.

(Reporting by Esha Dey in Bangalore; Editing by Sreejiraj Eluvangal)

((esha.dey@thomsonreuters.com)(within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800)(Reuters Messaging: esha.dey.thomsonreuters.com@reuters.net))

Keywords: NPSPHARMA FDA/STAFFBRIEFING

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