(Graphic from "Building a Business in Drug Safety," Jan. 2006, The RPM Report)
But sources close to Novartis note that the company had originally asked FDA not to simply pull the drug—but to contraindicate its use, with a black-box warning, for at-risk popualtions: older women and those with cardiovascular risk factors. The drug still should be available, Novartis argued, for younger women (roughly 40% of its users, who usually get severe constipation during menstruation).
FDA said no. Until the situation is more clearly understood, there was no reason to run the risk: IBS isn’t a fatal disease; there are—inadequate—alternatives; better safe than sorry, said the Agency.
Novartis was in no position to disagree. But it must be feeling picked on: the Zelnorm suspension is its second bit of bad regulatory news in weeks. Even worse: FDA’s “not yet” on Novartis’ most important pipeline drug, Galvus, back in January – while giving Merck’s competitive Januvia and Janumet the all clear – and what is likely an insuperable competitive lead.