Diabetes Drug CV Outcomes Trials May Be Needed For Market Success But Not Approval, US FDA Panel Says
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.
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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.
Diabetes Drugs: US FDA Proposes Hypoglycemia Efficacy Endpoints, With Limits
Reduction in the risk of hypoglycemia level 2 and 3 events, along with either a reduction or maintenance of an acceptable hemoglobin A1C, is a clinically relevant efficacy endpoint for drug development in Types 1 and 2 diabetes, FDA states in new draft guidance.