FDA Considers How Heart Patients Feel, Function, in New Draft Guidance

Regulators might be willing to approve heart failure drugs that make patients feel better even if they don’t keep patients out of the hospital — or even alive, the FDA said in a new draft guidance.

Some 6.5 million Americans suffer from heart failure and 30 percent of them spend time in hospitals every year. They tend to suffer from what the agency calls “troublesome symptoms” that affect their quality of life.

Medicines developed to treat heart disease have often improved patients’ everyday lives, but they’ve not made a dent in mortality rates — and in a few cases have actually worsened them. Regulators say they’re willing to consider quality of life over quantity.

“A drug that improves symptoms or function when added to standard of care would be valuable even if it did not improve survival or hospitalization,” the 10-page draft guidance says. “Moreover, it is possible that if a drug provided substantial and persistent improvement in symptoms or function… some decrease in survival would be acceptable.”