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FDAnews Drug Daily Bulletin
Oct. 16, 2012 | Vol. 9 No. 203
FDA Review Appears Positive for NPS’ Gattex Ahead of Advisory Meeting
The FDA appears to have a positive opinion of NPS Pharmaceuticals’ Gattex as a treatment for short bowel syndrome (SBS) patients, according to agency briefing documents. Although Gattex (teduglutide) did not meet its primary endpoint versus placebo in one trial, FDA reviewers cited a number of possible reasons for the missed mark. These included a change to a more rigorous measure for the primary endpoint. They also noted that a key secondary endpoint showed a nominal benefit.
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