Istaroxime, a dual action, luso-inotropic agent that’s still in clinical development, was granted fast-track designation by the FDA this month as a possible treatment for acute heart failure with reduced ejection fraction (HFrEF).
According to a release from Windtree Therapeutics, a Warrington, Pa., company that’s working to push istaroxime through to market, the agency’s August 13 designation will allow sponsors of istaroxime to communicate and interact with FDA officials more often, making the drug a priority that could receive quicker approval. The FDA reserves fast-track designation for drugs that could potentially address an unmet medical need—in this case HFrEF.
The designation is based on recently announced results from a Phase 2b study that found istaroxime improved cardiac function while maintaining or increasing blood pressure and decreasing heart rate during infusion in patients with acute heart failure. It’s injected intravenously and reportedly increases myocardial contractility through inhibition of Na+/K+ATPase. It also facilitates myocardial relaxation by activating the SERCA2a calcium pump.
Craig Fraser, president and CEO of Windtree Therapeutics, said in a statement the company was “very pleased” to receive the FDA’s 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,” he said. “Istaroxime is a novel, dual-action agent that impacts both the systolic and diastolic function of the heart. 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.”