scPharmaceuticals (NASDAQ:SCPH) has announced FDA approval of its supplemental NDA (sNDA) for FUROSCIX, expanding its indication to New York Heart Association (NYHA) Class IV chronic heart failure patients. Previously, FUROSCIX was only indicated for the treatment of congestion due to fluid overload NYHA Class II and Class III adult patients.
Patients with NYHA Class IV chronic heart failure represent 10% of all heart patients nationally and include those who are the most symptomatic as well as those with the greatest limitation on physical activity.
In a statement, John Tucker, CEO of scPharmaceuticals, said, “FDA approval of our sNDA represents a natural expansion of the FUROSCIX indication given its established efficacy and safety in treating congestion due to fluid overload in adult patients with chronic heart failure, offering the potential to prevent the need for heart failure-related hospital admission or readmission.
He added, “The growing adoption of FUROSCIX among cardiologists and heart failure specialists, together with our other FUROSCIX life cycle management initiatives, has created a solid foundation from which we plan to drive sustained long-term growth.”
