FDA Approves Expansion for Furosemide Injection to Treat Edema In Patients With CKD

Updated March 11, 2025.

The FDA approved an expanded indication for furosemide injection (Furoscix; scPharmaceuticals, Inc.) to include treating edema in adult patients with chronic kidney disease (CKD), including nephrotic syndrome. The expanded treatment is expected to be available by April 2025. In July 2024, the FDA accepted the supplemental new drug application that sought to expand the indication to include this population.^1,2

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The furosemide injection is currently approved for subcutaneous use as 80 mg/10 mL doses to treat congestion related to fluid overload in adult patients with heart failure. With this indication, the injection became the first and only FDA-approved subcutaneous loop diuretic that enables the delivery of intravenous (IV)-equivalent diuresis at home via the Furoscix On-Body Infusor. IV equivalence was demonstrated in a clinical study in which the furosemide injection demonstrated about 99.6% bioavailability (90% CI: 94.8%-104.8%) and 8-hour urine output of 2.7 L, which was similar to patients who received IV furosemide.^2,3

“We are thrilled to announce that the FDA has approved the sNDA for [furosemide injection], expanding the indication to include the treatment of edema in patients with chronic kidney disease. This milestone marks a significant step forward for the [furosemide injection] and underscores our commitment to addressing unmet needs of cardiorenal patients,” said John Tucker, CEO of scPharmaceuticals, in a news release. “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 [furosemide injection] to nephrologists and are focused on providing treatment options to both heart failure and CKD patients experiencing acute fluid overload.”⁴

It is contraindicated in patients with anuria or with a history of hypersensitivity to furosemide or medial adhesives. This updated indication did not need additional clinical studies, as furosemide demonstrated an adequate pharmacokinetic and pharmacodynamic bridge to the 10 mg/mL listed drug, according to FDA-provided Type D meeting feedback.²

“The potential expansion of the [furosemide injection] indication to include CKD could support a key long-term growth initiative... and an opportunity to improve the lives of [patients with CKD] as [the disease] affects more than 1 in 7 US adults and is characterized by frequent episodes of fluid overload,” said Tucker in a news release.²

In April 2024, it was announced that the first participant was enrolled in the pivotal pharmacokinetic study of furosemide 80 mg/mL (SCP-111), an investigational, low volume, pH-neutral formulation of furosemide administered via an auto-injector. The auto-injector is being developed as a complement to the FDA-approved On-body Infusor in an effort to provide patients with a subcutaneous injection and prescribers with treatment flexibility.^2,3

“Expanding the [furosemide injection] indication to include patients with CKD will provide a much-needed additional tool for clinicians to utilize in our management of fluid overload,” Suneel Udani, consulting physician at Nephrology Associates of Northern Illinois and Indiana, said in a news release. “Utilizing [furosemide injection] can potentially help us keep our patients with heart failure and/or CKD at home while we restore and maintain euvolemia.”⁴

REFERENCES

1. Stock Titan. 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. News release. March 6, 2025. Accessed March 6, 2025. https://www.stocktitan.net/news/SCPH/sc-pharmaceuticals-announces-fda-approval-of-supplemental-new-drug-tnsu5c1uzzr3.html

2. GlobeNewswire. scPharmaceuticals Announces Filing Acceptance of Supplemental New Drug Application (sNDA) Seeking to Expand FUROSCIX Indication to Include Chronic Kidney Disease. News release. July 25, 2024. Accessed March 5, 2025. https://www.globenewswire.com/en/news-release/2024/07/25/2918784/0/en/scPharmaceuticals-Announces-Filing-Acceptance-of-Supplemental-New-Drug-Application-sNDA-Seeking-to-Expand-FUROSCIX-Indication-to-Include-Chronic-Kidney-Disease.html

3. scPharmaceuticals. scPharmaceuticals Announces FDA Approval of FUROSCIX® (furosemide injection), the First and Only Self-administered, Subcutaneous Loop Diuretic for the At-home Treatment of Congestion in Chronic Heart Failure. News release. October 10, 2022. Accessed March 5, 2025. https://scpharmaceuticalsinc.gcs-web.com/news-releases/news-release-details/scpharmaceuticals-announces-fda-approval-furoscixr-furosemide

4.BioSpace. 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. News release. March 6, 2025. Accessed March 11, 2025. https://www.biospace.com/press-releases/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