Edoxaban Wins FDA Panel Nod On Approval But Mixed Verdict On Population, Dose
This article was originally published in The Pink Sheet Daily
Executive Summary
Cardio-renal committee votes 9-1 for approval of Daiichi’s anticoagulant for stroke risk reduction in patients with nonvalvular atrial fibrillation, but only five panelists said the currently proposed 60 mg dose should be approved for patients with normal renal function given adverse efficacy results in this subpopulation.
You may also be interested in...
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.
Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations
US FDA oncology officials are concerned that the entities sponsors are consulting in developing and implementing clinical trial diversity plans are not sufficiently diverse themselves and do not represent patients in underserved communities.
US FDA Drugs Center Launches Clinical Trial Innovation Hub With Demonstration Projects
CDER’s Center for Clinical Trial Innovation (C3TI) will support innovative clinical trial approaches designed to improve the quality and efficiency of drug development and regulatory decision-making. The initiative includes demonstration projects on Bayesian analyses, selective safety data collection and point-of-care trials.