FDA Expands Furosemide Injection Label to Treat Edema in CKD

The FDA approved the label expansion for furosemide injection (Furoscix; scPharmaceuticals) to treat edema caused by fluid buildup in patients with chronic kidney disease (CKD), including nephrotic syndrome.1

Last year, the drug developer noted that FDA feedback from a 2023 Type D meeting confirmed no additional clinical trials would be needed to approve the label expansion.2

“Expanding the [furosemide] 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,” Suneel Udani, MD, a consulting physician at Nephrology Associates of Northern Illinois and Indiana, said in a statement.1 “Utilizing [furosemide] can potentially help us keep our patients with heart failure and/or CKD at home while we restore and maintain euvolemia.”

An estimated 35.5 million US adults have CKD as of 2023, making up 14% of the population.3 However, according to the CDC, as many as 9 in 10 adults aren’t aware they have CKD, and by the time is becomes severe, about 1 in 3 still do not know they have it.

CKD is defined as at least 3 months of kidney damage, making it harder for the kidneys to do their job of removing natural waste and excess water from the body, balance important minerals, help make blood cells and maintain blood pressure, and more.4 CKD can also increase the risk of other health problems such as heart disease and stroke.

Furosemide injection was previously approved to treat congestion from fluid buildup in adults with chronic heart failure. | Image credit: Abinash T/Wirestock Creators – stock.adobe.com

Furosemide injection was previously approved in 2022 to treat congestion from fluid buildup in adults with chronic heart failure, making it the first at-home, self-administered subcutaneous loop diuretic approved in the US.5 For patients with heart failure, the device works by inserting the pre-filled cartridge into the pre-programmed single-use on-body infuser, attaching the infuser to the abdomen, and pressing a button to release the 80 mg dose over the course of 5 hours. According to scPharmaceuticals, this injection is not advised to be used in an emergency.2

"We are thrilled to announce that the FDA has approved the sNDA for [furosemide], 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] franchise and underscores our commitment to addressing unmet needs of cardiorenal patients," John Tucker, MBA, CEO of scPharmaceuticals, said in a statement.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 [furosemide] to nephrologists and are focused on providing treatment options to both heart failure and CKD patients experiencing acute fluid overload."

In clinical trials, the most common adverse events reported after receiving the injection included site and skin reactions like erythema, bruising, edema, and injection site pain.2

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. scPharmaceuticals announces filing acceptance of supplemental new drug application (sNDA) seeking to expand FUROSCIX indication to include chronic kidney disease. scPharmaceuticals. July 25, 2024. Accessed March 6, 2025. https://scpharmaceuticalsinc.gcs-web.com/news-releases/news-release-details/scpharmaceuticals-announces-filing-acceptance-supplemental-new
3. Chronic kidney disease in the United States, 2023. CDC. 2023. Accessed March 6, 2025. https://www.cdc.gov/kidney-disease/php/data-research/index.html
4. NKF Patient Education Team. Chronic kidney disease (CKD). National Kidney Foundation. Updated September 11, 2023. Accessed March 6, 2025. https://www.kidney.org/kidney-topics/chronic-kidney-disease-ckd
5. 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. October 10, 2022. Accessed March 6, 2025. https://scpharmaceuticalsinc.gcs-web.com/news-releases/news-release-details/scpharmaceuticals-announces-fda-approval-furoscixr-furosemide