Diabetes Drug CV Outcomes Trials May Be Needed For Market Success But Not Approval, US FDA Panel Says
Executive Summary
Longer, broader premarketing trials should replace the requirement for dedicated outcomes trials to demonstrate CV safety, but competitive pressure may drive sponsors to voluntarily conduct outcomes studies to demonstrate CV benefit, FDA advisory committee members said.
You may also be interested in...
US FDA Panel Will Reckon With Need For Diabetes Drug CV Risk Assessments
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.
Merck Blocked In Adding CV Claim For Januvia, May Fall Behind Victoza
Merck got a complete response letter from FDA on a cardiovascular risk-reduction claim for the DPP-4 inhibitor based on TECOS trial data. This places Januvia/Janumet behind Jardiance, which already has a CV safety label claim, and Victoza, which awaits an FDA decision on a supplemental NDA filed last October.
Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing
Commissioner Robert Califf discussed the agency’s request for $12.3m to address shortages and legislation to require that manufacturers provide more detailed information about increased demand and supply chain vulnerabilities.