Nasdaq-listed scPharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for a supplemental new drug application (sNDA) concerning Furoscix (furosemide injection).
This approval broadens the medication’s application to include treating edema in patients diagnosed with chronic kidney disease (CKD), signifying a substantial development in scPharmaceuticals’ portfolio targeting cardiorenal conditions.
Furoscix, containing an 80 mg/10 mL dose of furosemide for subcutaneous injection, is now cleared to manage edema. It encompasses symptoms such as congestion, fluid overload, and hypervolemia in adult individuals with either chronic heart failure or CKD, including those with nephrotic syndrome.
scPharmaceuticals CEO John Tucker said: “This milestone marks a significant step forward for the Furoscix franchise and underscores our commitment to addressing unmet needs of cardiorenal patients.
“In anticipation of this approval, we have taken strategic steps to ensure a successful launch, including key opinion leader engagement, comprehensive market research, and commercial readiness initiatives. We are excited to introduce Furoscix to nephrologists and are focused on providing treatment options to both heart failure and CKD patients experiencing acute fluid overload.”
In October 2022, scPharmaceuticals had announced receiving FDA approval for Furoscix as the first self-administered subcutaneous loop diuretic for at-home treatment of congestion linked to chronic heart failure.
Furoscix at that time was permitted by the FDA for its use in adult patients exhibiting congestion because of fluid overload associated with New York Heart Association (NYHA) Class II and Class III chronic heart failure.
In August 2024, the approval was extended for the inclusion of NYHA Class IV heart failure sufferers, who are the most symptomatic and have significant limitations on physical activities. This group constitutes approximately 10% of all cases of heart failure across the US.
