FDA Committee Votes in Support of Reintroducing Novartis’ IBS Drug

An FDA advisory committee voted in favor of a supplemental new drug application for Novartis’ Zelnorm (tegaserod maleate) for treatment of women with irritable bowel syndrome-constipation (IBS-C).

The Gastrointestinal Drugs Advisory Committee voted 11-1 in support of the SNDA. The committee voted 12-0 that the therapeutic gain for the drug was generally similar in severely symptomatic and originally approved populations.

The expert group also voted on the specific populations for which they expected the benefits of the drug to outweigh the risks. Seven members said IBS-C females are at low cardiovascular risk from the drug.