The U.S. Food and Drug Administration granted fast-track designation to Windtree Therapeutics Inc.'s heart failure drug.
The Warrington, Pa.-based biotechnology company is developing istaroxime to treat symptoms of acute heart failure, a disease characterized by the sudden appearance or abrupt worsening of symptoms of heart failure.
Results from the company's phase 2 study showed that istaroxime improved cardiac function in patients with acute heart failure compared to placebo. The drug also maintained or increased blood pressure and decreased heart rate during the infusion in the mid-stage study.
The U.S. regulator grants fast-track designations to expedite the review of drugs that treat serious conditions and fill unmet medical needs. Incentives include frequent meetings and communications with the FDA and potential accelerated approval, priority review or rolling review.