Drugs

Support for Heart Failure Endpoints Guidance

Pfizer says it supports an FDA 6/2019 draft guidance on drug development endpoints for treating heart failure. The company comment letter says the guidance “is positive in that large mortality trials may not be needed for a heart failure indication. Rather, based on the draft guidance, now studies could be powered, if appropriate, based on alternative endpoints (such as symptoms and/or function) which could lead to smaller and/or shorter clinical trials.”

AstraZeneca says it believes the draft “will facilitate and expedite development of new therapies for the treatment of this serious condition. It also provides helpful context for future consultation meetings with the review divisions.”

Novartis wants further guidance on how the endpoints can translate into labeling. In particular, it says, the indication should reflect the study endpoints supporting approval. It also includes questions that arose from the 7/26/19 agency public meeting on the draft guidance.

The Heart Failure Society of America commends FDA for the approach taken in the draft, recognizing that an effect on symptoms or physical function, with or without a favorable effect on survival or risk of hospitalization, can be a basis for approving drugs to treat heart failure. “We also believe that since heart failure is a clinical diagnosis, there is a need for increased consideration of patient-centered metrics such as physical function and quality of life when evaluating the efficacy of pharmacologic therapies,” the society says. Its letter covers these considerations for endpoints: patient-reported outcomes, mortality and morbidity, hospitalizations, and adjudication.

Each stakeholder included specific line-by-line comments, as did Eli Lilly.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome