scPharmaceuticals Inc. (SCPH) announced on Monday that the U.S. Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (sNDA) to extend the indication of FUROSCIX for heart failure patients.
FUROSCIX is prescribed to alleviate congestion caused by fluid overload in adult patients suffering from chronic heart failure.
Originally, FUROSCIX was specifically indicated for treating congestion in adult patients classified under the New York Heart Association (NYHA) Class II and Class III chronic heart failure.
The newly approved expanded indication now encompasses NYHA Class IV chronic heart failure patients. This group represents the most symptomatic individuals, with the greatest limitations on physical activity, accounting for approximately 10% of all heart failure patients in the U.S.
John Tucker, Chief Executive Officer of scPharma, stated, “The FDA's approval of our sNDA is a natural progression of FUROSCIX's established efficacy and safety in treating fluid overload in adult patients with chronic heart failure. This approval offers the potential to reduce the necessity for heart failure-related hospital admissions or readmissions.”
The company also highlighted that FUROSCIX is contraindicated in patients with anuria, those with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation or medical adhesives, and in patients with hepatic cirrhosis.
Furosemide may induce fluid, electrolyte, and metabolic imbalances, particularly in patients receiving higher doses, those with insufficient oral electrolyte intake, and elderly patients.
In pre-market trading on Nasdaq, scPharma shares dropped by approximately 9.7%, trading at $3.91.
