The New Zelnorm-al: US FDA’s Do-Over On Cardiovascular Safety
Zelnorm’s revival is self-conscious effort to revisit a decision made in “Safety First” era a decade ago. Is dropping CV outcomes standard for diabetes drugs next?
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An October US FDA advisory committee meeting to discuss type 2 diabetes drug cardiovascular safety standards replayed a July 2008 meeting, but in a more harmonious key. That reflects the changing climate for FDA – but also a change in who was invited to participate.
Looming return of Zelnorm to US market is milestone event for current regulatory climate. But FDA’s hands-on work to resurrect a different 5HT4 agonist, prucalopride, probably says more about what is truly different about the agency today.
Cardiovascular and non-CV safety findings from completed outcomes trials to date for eight drugs, as well as the relative paucity of preapproval CV data available for anti-diabetic agents prior to a December 2008 guidance that mandated dedicated risk assessments, may inform advisory committee's view on continuing need for large safety trials.