FDA Approves FUROSCIX On-Body Injector for Pediatric Patients, Accepts sNDA for ReadyFlow Autoinjector

Announced by parent company MannKind Corporation on December 23, 2025, the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the furosemide On-body Infusor (FUROSCIX) to treat edema associated with chronic heart failure (HF) and chronic kidney disease (CKD) in pediatric patients weighing ≥43 kg.1

“We are pleased to make FUROSCIX available to the pediatric population, a highly specific patient group, offering a convenient option outside the hospital setting for those who meet the weight criteria,” Ajay Ahuja, MD, MBA, chief medical officer of MannKind Corporation, said in a statement.1

The FUROSCIX On-body Infusor was initially approved in 2022 for the treatment of edema in adults with chronic HF; later, in 2025, it received approval for adults with CKD as well. This third approval fulfills all post-marketing requirements outlined in the initial approval letter under the Pediatric Research Equity Act.1

Furosemide’s initial approval was based on data from the phase 2 AT HOME-HF pilot study, a multicenter, randomized trial investigating subcutaneous furosemide 80 mg/10 mL versus standard of care in 51 patients with chronic HF and worsening congestion, uncontrolled by diuresis. The primary endpoint was a win ratio of a 30-day hierarchy composite of cardiovascular death, HF events, and change in N-terminal pro-B-type natriuretic peptide (NT-proBNP). Secondary endpoints included dyspnea severity, functional capacity, and quality of life.2

Ultimately, 51 patients were enrolled and randomly assigned in a 2:1 ratio to either furosemide (n = 34) or standard of care (n = 17). Furosemide displayed greater reductions in body weight; between-group difference in least square mean change was -2.02 kg at day 3 (95% CI, -3.9 to -0.14; P = .035). Additionally, the furosemide-to-standard-of-care win ratio was 1.11 (95% CI, 0.48 to 2.5; P = .806). The most common adverse event with furosemide at the time was mild infusion site pain (11.8%).2

In the same release, MannKind announced the FDA’s acceptance of a separate sNDA for the FUROSCIX ReadyFlow Autoinjector for adult patients with chronic HF or CKD. Unlike the On-body Infusor, the ReadyFlow is designed to deliver a subcutaneous furosemide injection in <10 seconds. If approved, the device could provide patients with a method of managing fluid buildup from home, eliminating the need for hospital admission.3

“The FUROSCIX ReadyFlow Autoinjector marks a key milestone in expanding patient options and improving care,” Michael Castagna, PharmD, chief executive officer at MannKind Corporation, said in a separate statement regarding the acceptance. “By delivering treatment in under 10 seconds, the ReadyFlow Autoinjector has the potential to transform how adults with chronic heart failure or chronic kidney disease manage episodes of fluid buildup—providing faster relief, reducing hospital admissions, and lowering overall healthcare costs.”3

The FUROSCIX ReadyFlow Autoinjector has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2026.3

References

1. MannKind Corporation. MannKind Shares FUROSCIX Business Updates. December 23, 2025. Accessed December 23, 2025. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-shares-furoscixr-business-updates

2. Konstam MA, Massaro J, Dhingra R, et al. Avoiding Treatment in Hospital With Subcutaneous Furosemide for Worsening Heart Failure: A Pilot Study (AT HOME-HF). JACC Heart Fail. 2024;12(11):1830-1841. doi:10.1016/j.jchf.2024.07.015

3. MannKind Corporation. MannKind Announces U.S. FDA Accepts for Review its Supplemental New Drug Application (sNDA) of FUROSCIX ReadyFlow Autoinjector for the Treatment of Edema in Adults with Chronic Heart Failure or Chronic Kidney Disease. December 1, 2025. Accessed December 23, 2025. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-us-fda-accepts-review-its-supplemental-new