FDA: More Heart Failure Meds Needed, Even If They Don’t Lower Mortality

In draft guidance released Thursday (June 27), FDA clarifies that it wants to stimulate development of drugs that treat heart failure, even if the drugs only help improve patients’ physical function and lifestyle, but do not improve patients’ overall survival rates or decrease hospitalization rates. The guidance is intended to correct a misguided belief among stakeholders that decreases in mortality and morbidity are required for FDA to approve a heart failure drug, the agency says in the document. However, FDA...