FDA Approves Furosemide Injection (Furoscix) for Edema in CKD

The US Food and Drug Administration has approved scPharmaceuticals’ supplemental New Drug Application (sNDA) for furosemide (Furoscix), expanding its indication to include the treatment of edema in patients with chronic kidney disease (CKD).1

Announced on March 6, 2025, the expanded indication means furosemide injection, 80 mg/10 mL for subcutaneous use is now approved for the treatment of edema, including congestion, fluid overload, or hypervolemia, in adult patients with chronic heart failure or CKD, including the nephrotic syndrome.1

“Expanding the FUROSCIX indication to include patients with chronic kidney disease will provide a much-needed additional tool for clinicians to utilize in our management of fluid overload,” said Suneel Udani, MD, a consulting physician at Nephrology Associates of Northern Illinois and Indiana.1 “Utilizing FUROSCIX can potentially help us keep our patients with heart failure and/or CKD at home while we restore and maintain euvolemia.”

Type D meeting feedback provided by the FDA in 2023 confirmed no additional clinical studies would be needed to expand the indication so long as scPharmaceuticals could demonstrate an adequate pharmacokinetic and pharmacodynamic bridge to the listed drug, furosemide injection 10 mg/mL.2

"We are thrilled to announce that the FDA has approved the sNDA for FUROSCIX, expanding the indication to include the treatment of edema in patients with chronic kidney disease. This milestone marks a significant step forward for the FUROSCIX franchise and underscores our commitment to addressing unmet needs of cardiorenal patients," said John Tucker, chief executive officer of scPharmaceuticals.1 "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."

According to the release from scPharmaceuticals, furosemide is expected to be available for CKD patients in April 2025.1

Furosemide injection first earned FDA approval in October 2022 for the treatment of congestion due to fluid overload in adults with New York Heart Association (NYHA) Class II/III chronic heart failure. The indication made it the first and only FDA-approved subcutaneous loop diuretic enabling the delivery of IV equivalent diuresis at home via the FUROSCIX infusor.2

In August 2024, the FDA approved an sNDA expanding the indication for heart failure patients to include those with NYHA Class IV chronic heart failure.3

Additionally, scPharmaceuticals is developing an autoinjector as a complement to the FDA-approved on-body infusor to allow for the subcutaneous administration of a low-volume furosemide formulation. In August 2024, positive topline results from the pharmacokinetic study of SCP-111 (furosemide 80 mg/mL) showed the autoinjector achieved the trial’s primary pharmacokinetic and secondary pharmacodynamic endpoints, including bioavailability, urine output, urinary sodium excretion, urinary potassium excretion, and median pain scores.4

References

1. scPharmaceuticals. scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the FUROSCIX® Indication to Include the Treatment of Edema in Patients with Chronic Kidney Disease. March 6, 2025. Accessed March 6, 2025. https://ir.scpharmaceuticals.com/news-releases/news-release-details/scpharmaceuticals-announces-fda-approval-supplemental-new-drug-0

2. Brooks A. FDA Accepts sNDA for Furosemide (Furoscix) in Chronic Kidney Disease. HCPLive. July 25, 2024. Accessed March 3, 2025. https://www.hcplive.com/view/fda-accepts-snda-furosemide-furoscix-chronic-kidney-disease

3. scPharmaceuticals. scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the FUROSCIX Indication in Heart Failure. August 12, 2024. Accessed March 3, 2025. https://scpharmaceuticalsinc.gcs-web.com/news-releases/news-release-details/scpharmaceuticals-announces-fda-approval-supplemental-new-drug

4. scPharmaceuticals. scPharmaceuticals Announces Positive Topline Study Results for SCP-111 (Furosemide 80 mg/1 mL) Autoinjector. August 12, 2024. Accessed March 3, 2025. https://ir.scpharma.com/news-releases/news-release-details/scpharmaceuticals-announces-positive-topline-study-results-scp