The U.S. Food and Drug Administration (FDA) granted its Fast Track Designation to islaroxime, which is used for the treatment of acute heart failure. Islaroxime was developed by Windtree Therapeutics Inc., a biotechnology and medical device company.
"We are very pleased to receive FDA's Fast Track Designation for istaroxime," Craig Fraser, President and CEO, said. "This Fast Track designation for istaroxime underscores the significant unmet medical need to treat patients suffering from acute heart failure and the potential of istaroxime as demonstrated by the phase 2 clinical results.
"Istaroxime is a novel, dual-action agent that impacts both the systolic and diastolic function of the heart in patients hospitalized with acute heart failure. In recently announced results from a Phase 2b study evaluating istaroxime in acute heart failure patients, we achieved our primary objective of improved cardiac function, while maintaining or increasing blood pressure and decreasing heart rate during the infusion. Additionally, we observed a well characterized safety profile for istaroxime. We look forward to continuing our work with the FDA and the cardiology community to advance istaroxime through clinical development and the regulatory approval process, with the goal of bringing to market a transformative therapy to treat acute heart failure patients."
The Fast Track Designation is designed for drugs developed for the treatment of serious or life-threatening diseases and conditions which prove it has the potential to meet an unmet need. The designation expedites the review and approval process.
