Drugs

Heart Failure Drug Development Guidance

FDA has published a draft guidance, Treatment for Heart Failure: Endpoints for Drug Development, giving the agency’s current thinking about developing drugs to treat heart failure and highlighting remaining areas of uncertainty to encourage discussion and alternative approaches. The document’s purposes are to (1) make it clear that an effect on symptoms or physical function, without a favorable effect on survival or risk of hospitalization, can be a basis for approving drugs to treat heart failure; and (2) to provide recommendations to sponsors on the need to assess mortality effects of drugs under development to treat heart failure.

The guidance pertains primarily to treating chronic heart failure. Development of drugs to treat acute heart failure and pediatric considerations are discussed briefly. It applies to both heart failure with reduced ejection fraction and heart failure with preserved ejection fraction.

Topics covered in the draft are Introduction, Background, Mortality Data: Purpose and Requirements, Efficacy Endpoints Related to How Patients Feel and Function, Hospitalization and Outpatient Intervention, Biomarkers and Surrogate Endpoints, Acute Heart Failure, Heart Failure with Preserved Ejection Fraction, and Heart Failure in the Pediatric Population.

An FDA news release says the agency will hold a 7/26 public workshop “to bring the stakeholder community together to discuss clinical endpoints for trials in heart failure that could be used to support FDA approval of drugs. In addition, there will be discussion of the need to assess mortality effects of drugs under development for heart failure.”

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