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


Oct 12 (Reuters) - U.S. drug reviewers found three seriousconcerns related to NPS Pharmaceuticals Inc'sexperimental drug for short bowel syndrome, but said they didnot think the drug needed to be restricted for safety reasons,according to documents posted by the Food and DrugAdministration on its website Friday.

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

The three risks observed by the FDA staff aregastrointestinal obstruction, biliary and pancreatic disordersand an acceleration in the growth of new tissue and colonpolyps.htt p://link.reuters.com/nuq33t

The staff said that the drug's approval would warrant a riskevaluation and mitigation strategy and supported the plansproposed by the company.

However, it added that access to Gattex should not berestricted and the drug did not require any further assessmentto assure safe use as it would be prescribed by skilledphysicians and specialists.

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

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

(Reporting by Esha Dey in Bangalore; Editing by SreejirajEluvangal)

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