Istaroxime new drug for acute heart failure gets fast track designation from FDA

Istaroxime new drug for acute heart failure gets fast track designation from the FDA .

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to istaroxime for the treatment of acute heart failure. The Fast Track Designation for the drug has been granted to M/sWindtree Therapeutics, Inc. (OTCQB: WINT), a biotechnology and medical device company that focuses on developing drug product candidates and medical device technologies to address acute cardiovascular and pulmonary diseases.

Istaroxime is a first-in-class, dual-action, luso-inotropic agent in clinical development for the treatment of acute heart failure with reduced ejection fraction. Istaroxime is an intravenously administered agent with a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+-ATPase. In addition, it facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm.

"We are very pleased to receive FDA's Fast Track Designation for istaroxime. 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," commented Craig Fraser, President, and Chief Executive Officer. "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."

A drug may be granted Fast Track Designation if it is being developed for the treatment of a serious or life-threatening disease or condition and it demonstrates the potential to address an unmet medical need. The purpose of the Fast Track Designation is to facilitate the development and expedite the review and potential approval of drugs to treat serious and life-threatening conditions.

Sponsors of drugs that receive Fast Track Designation have the opportunity for more frequent communications and interactions with FDA throughout the development program. These can include meetings to discuss study design, data required to support approval, or other aspects of the clinical program. Additionally, products that have been granted Fast Track Designation may be eligible for priority review of a New Drug Application (NDA) and FDA may consider reviewing portions of an NDA before the sponsor submits the complete application (Rolling Review).