Regeneron Seeks Heart Failure Guidance Clarifications

Regeneron is commenting on an FDA draft guidance on drug development endpoints for treating heart failure “to assist the agency in enhancing the clarity of the recommendations provided to industry and key stakeholders. We believe these clarifications will strengthen guidance on the appropriate endpoints to include in heart failure clinical trials and help ensure the timely approval of new therapies to address the severe unmet needs of these populations.” The company letter recommends that the agency: 

•          create further opportunities for dialog with other regulators such as the European Medicines Agency or the Pharmaceutical and Medical Devices Agency to help focus on aligning programs intended to support global development of new drugs for treating heart failure; and
•          clarify whether improvement of cardiorenal syndrome could be an approval endpoint in heart failure clinical trials.

The letter also includes line-by-line specific recommendations.