FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Windtree Earns Fast Track Designation for Heart Failure Drug

Aug. 16, 2019
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Windtree Therapeutics’ investigational drug istaroxime has nabbed a fast track designation from the FDA for the treatment of acute heart failure.

The novel, dual-action agent works on both the systolic and diastolic functions of the heart in patients hospitalized with acute heart failure.

The drugmaker said that results from a phase 2 study of istaroxime in acute heart failure patients met the primary objective of improved cardiac function while increasing or maintaining blood pressure and lowering heart rate during infusion. Additionally, Windtree said it “observed a well characterized safety profile” for the drug.

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