BioCentury
ARTICLE | Clinical News

Patient preferences could influence mortality requirements in heart failure

July 26, 2019 10:45 PM UTC

Companies that were seeking more clarity on mortality requirements of heart failure therapies that provide symptomatic benefit didn't get it at a Friday workshop hosted by FDA. Instead, doctors and patients suggested that multiple factors could affect exactly how much mortality risk should be ruled out, but most do not see a viable commercial path for a drug that improves symptoms but has mortality risks.

FDA held the public workshop to discuss its draft guidance on new symptomatic and functional endpoints for heart failure therapies. The guidance, issued last month, outlined potential new primary endpoints outside of mortality and hospitalization that could be used to support approval of new agents to treat HF...