Posted by Michael Wonder on 27 Jun 2019
FDA takes steps to spark development of heart failure drugs
27 June 2019 - The draft guidance, Treatment for Heart Failure: Endpoints for Drug Development, when finalised, will describe the agency’s current thinking on efficacy endpoints related to how patients feel and function, noting that evidence of effectiveness of a heart failure drug could be based on improvements in symptoms, such as fatigue, and/or function, such as walking.
Additionally, the draft guidance describes how to assess hospitalisation as a clinical outcome and discusses possible biomarkers and surrogate outcomes.
It also highlights several specific areas that are in need of further discussion, for which the FDA is seeking public input.
