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.
Drug Industry Daily