On Wednesday, October 17, 2018, the Gastrointestinal Drug Products Advisory Committee (GIDAC) met to discuss a supplemental new drug application (sNDA) for Zelnorm (tegaserod maleate) tablets for oral administration, submitted by Sloan Pharma S.à.r.l, Bertrange, Cham Branch (Sloan). Note that the Investigational New Drug (IND) application for Zelnorm was transferred from its initial holder, Novartis, to Sloan on November 24, 2015, and US World Meds, LLC is acting as an authorized agent for Sloan on the sNDA.
A majority of the Committee, 7 of 12 members, voted that “IBS-C females at low CV risk” is the patient population in whom they would expect the benefits to outweigh the risks. Three of 12 members voted that “IBS-C females at low CV risk and who are severely symptomatic” is the patient population in whom they would expect the benefits to outweigh the risks. One committee member voted that “IBS-C females,” with no qualification for CV risk, is the patient population in whom the benefits are expected to outweigh the risks. He elaborated that although the indication should be kept broad, labeling should include information about the both safety signals to guide prescribing. One Committee member voted for “other” because she felt the appropriate population is IBS-C females at low CV risk who are severely symptomatic and who are also at low psychiatric risk.