FDA Accepts sNDA for Furosemide (Furoscix) in Chronic Kidney Disease

scPharmaceuticals has announced the US Food and Drug Administration (FDA)’s acceptance of a supplemental New Drug Application (sNDA) to expand the indication for furosemide (Furoscix) to include the treatment of edema due to fluid overload in patients with chronic kidney disease (CKD).¹

According to a July 25, 2024, press release, Type D meeting feedback provided by the FDA last year 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. With the acceptance of filing for the sNDA, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025.^1,2

“The potential expansion of the FUROSCIX indication to include CKD could support a key long-term growth initiative for our Company, and an opportunity to improve the lives of CKD patients as CKD affects more than 1 in 7 US adults and is characterized by frequent episodes of fluid overload.” John Tucker, chief executive officer of scPharmaceuticals, said in a press release.¹ “We look forward to the review of our application by the FDA and are preparing to deploy additional commercial resources, if our sNDA is approved, to efficiently address what we estimate to be a $3 billion addressable market.”

Furosemide injection first earned FDA approval on October 10, 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. Once the pre-filled cartridge is inserted into the pre-programmed single-use on-body infusor for FUROSCIX and attached to the abdomen, the device is activated with the press of a button to deliver an 80-mg dose over the course of 5 hours.³

Additionally, scPharmaceuticals is developing an auto-injector as a complement to the FDA-approved on-body infusor to allow for the subcutaneous administration of a low-volume furosemide formulation. Enrollment of the first participant in a pharmacokinetic study of SCP-111 (furosemide 80 mg/mL) was announced on April 24, 2024, with topline data expected during Q3 and potential sNDA submission by the end of 2024. In the same press release, scPharmaceuticals announced the advancement of a pair of label expansion initiatives with the current on-body infusor, including NYHA Class IV heart failure and CKD.⁴

“It is estimated that 12-15 million Americans are aware that they have kidney disease and 50% of patients with CKD do not have a diagnosis of heart failure. With fluid overload being one of the most common complications in CKD, which worsens with disease progression, we believe FUROSCIX could be beneficial to patients with CKD who have worsening symptoms due to fluid overload and are not responding to oral loop diuretics. We plan to advance FUROSCIX as we work towards our goal of introducing a new treatment option to CKD patients with edema as efficiently as possible,” Tucker said.²

References

1. ^{scPharmaceuticals. scPharmaceuticals Announces Filing Acceptance of Supplemental New Drug Application (sNDA) Seeking to Expand FUROSCIX Indication to Include Chronic Kidney Disease. July 25, 2024. Accessed July 25, 2024. https://scpharmaceuticalsinc.gcs-web.com/news-releases/news-release-details/scpharmaceuticals-announces-filing-acceptance-supplemental-new}
2. ^{scPharmaceuticals. scPharmaceuticals Announces Positive Feedback from Two FDA Meetings on Key Long-Term Growth Initiatives. September 19, 2023. Accessed July 25, 2024. https://scpharmaceuticalsinc.gcs-web.com/news-releases/news-release-details/scpharmaceuticals-announces-positive-feedback-two-fda-meetings}
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. October 10, 2022. Accessed July 25, 2024. https://scpharmaceuticalsinc.gcs-web.com/news-releases/news-release-details/scpharmaceuticals-announces-fda-approval-furoscixr-furosemide}
4. ^{scPharmaceuticals. scPharmaceuticals Announces First Participant Enrolled in Pivotal Pharmacokinetic Study of FUROSCIX Auto-Injector (furosemide 80mg/mL) Injection. April 24, 2024. Accessed July 25, 2024. https://scpharmaceuticalsinc.gcs-web.com/news-releases/news-release-details/scpharmaceuticals-announces-first-participant-enrolled-pivotal}