FDA Expands Furoscix Approval to Include Edema Treatment in CKD Patients
核心洞察
The FDA has approved scPharmaceuticals' supplemental New Drug Application for Furoscix, extending its use to treat edema (搜索) in chronic kidney disease (搜索) patients, with availability expected in April 2025.
Furoscix becomes the first subcutaneous loop diuretic approved for both heart failure and CKD patients, offering an at-home alternative to traditional IV diuretic therapy.
The approval was granted without requiring additional clinical studies, based on demonstrating adequate pharmacokinetic and pharmacodynamic equivalence to standard furosemide injection.
The U.S. Food and Drug Administration has expanded the approval of Furoscix (furosemide injection) to include the treatment of edema (搜索) in patients with chronic kidney disease (搜索) (CKD), marking a significant advancement in at-home fluid management options for these patients.
The expanded indication, announced on March 6, 2025, approves the use of furosemide injection (80 mg/10 mL) for subcutaneous administration to treat edema (搜索), including congestion, fluid overload, or hypervolemia, in adult patients with either chronic heart failure (搜索) or CKD, including those with nephrotic syndrome (搜索).
Clinical Impact and Treatment Innovation
"Expanding the FUROSCIX indication to include patients with chronic kidney disease (搜索) will provide a much-needed additional tool for clinicians to utilize in our management of fluid overload," stated Dr. Suneel Udani from Nephrology Associates of Northern Illinois and Indiana (搜索). He emphasized that FUROSCIX could help maintain patients with heart failure and/or CKD at home while achieving and maintaining proper fluid balance.
The approval process was streamlined after FDA Type D meeting feedback in 2023 confirmed that no additional clinical studies would be necessary. The expansion required only demonstration of adequate pharmacokinetic and pharmacodynamic bridging to the reference furosemide injection 10 mg/mL.
Commercial Launch and Availability
John Tucker, CEO of scPharmaceuticals, expressed enthusiasm about the approval: "This milestone marks a significant step forward for the FUROSCIX franchise and underscores our commitment to addressing unmet needs of cardiorenal patients." The company has implemented strategic preparations for the launch, including key opinion leader engagement and commercial readiness initiatives. The treatment is expected to be available for CKD patients starting April 2025.
Development History and Future Plans
Furoscix initially received FDA approval in October 2022 for treating congestion due to fluid overload in adults with NYHA Class II/III chronic heart failure (搜索), establishing itself as the first FDA-approved subcutaneous loop diuretic for at-home use. The indication was further expanded in August 2024 to include NYHA Class IV chronic heart failure patients.
ScPharmaceuticals is also developing an autoinjector complement to the approved on-body infusor. Recent positive topline results from the pharmacokinetic study of SCP-111 (furosemide 80 mg/mL) demonstrated achievement of primary pharmacokinetic and secondary pharmacodynamic endpoints, including satisfactory bioavailability and various urinary parameters.