FDA Approves Furoscix ReadyFlow, the First and Only Autoinjector Delivering IV-Equivalent Diuretic Therapy for the Treatment of Edema in Adults with Heart Failure or Chronic Kidney Disease – MannKind
MannKind Corporation announced that the FDA has approved Furoscix ReadyFlow (furosemide injection) for the treatment of edema (fluid overload) in adults with heart failure (HF) or chronic kidney disease (CKD). Furoscix ReadyFlow is an at-home treatment option designed to help adults with heart failure or chronic kidney disease address fluid overload earlier, before worsening symptoms may lead to emergency department visits, hospitalization, or readmission. As the first and only autoinjector delivering subcutaneous furosemide with IV-equivalent exposure (based on comparisons of AUC and PD endpoints), Furoscix ReadyFlow provides a full 80 mg/mL dose in a simple, patient-friendly format administered in under 10 seconds. The therapy is absorbed into the bloodstream, and symptom relief may begin in an hour or less. Together, these attributes may help expand opportunities for earlier intervention and extend IV-equivalent furosemide exposure beyond the hospital for appropriate patients across outpatient, post-discharge and home-based care settings.
“Too often, patients living with heart failure or chronic kidney disease find themselves caught in a cycle of worsening fluid overload that can disrupt daily life and lead to ER visits and hospitalization,” said Hunter Champion, MD, PhD, Emory University Healthcare Network and Director of the Heart Failure and Pulmonary Hypertension program at Southeastern Cardiology Associates in Columbus, Georgia. “An at-home option that delivers similar IV-equivalent furosemide exposure through a simple autoinjector gives clinicians an important new tool to intervene as soon as signs and symptoms of fluid overload appear helping appropriate patients manage congestion outside the hospital setting while reducing the disruption and burden associated with hospital-based treatment.”
Heart failure affects approximately 6.7 million adults in the United States and is projected to increase to more than 8 million by 2030. Fluid overload is a primary driver of worsening symptoms and one of the most common reasons patients with heart failure or chronic kidney disease require emergency department visits, hospitalization, or readmission. Chronic kidney disease frequently coexists with heart failure and can further complicate fluid management, increasing the risk of recurrent events. Heart failure remains one of the costliest chronic conditions in the United States, with hospitalizations accounting for approximately 80% of heart failure-related healthcare costs. By 2030, heart failure costs in the United States are expected to be at least $70 billion per year.
Together, these dynamics underscore the need for outpatient treatment options that can help appropriate patients receive timely intervention for worsening fluid overload before hospital-based care may become necessary.
“The approval of Furoscix ReadyFlow marks an important milestone for patients living with heart failure or chronic kidney disease who experience fluid overload,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “By combining IV-equivalent diuretic performance with the simplicity of an autoinjector, Furoscix ReadyFlow has the potential to advance how fluid overload is managed outside traditional care settings and reach appropriate patients at different intervention points—from the onset of worsening symptoms and, when hospitalization cannot be avoided, through the transition home. We believe this represents a meaningful step forward for patients, practitioners, payers and hospitals—helping ease fluid burden for patients while reducing pressure on an increasingly burdened healthcare system.”
The FDA approval is supported by positive clinical data demonstrating that Furoscix ReadyFlow achieved its primary pharmacokinetic endpoint. The study also demonstrated equivalent urine output, sodium excretion and potassium excretion at 6, 8 and 12 hours compared to IV furosemide. Furoscix ReadyFlow was generally well tolerated, with a safety profile consistent with known effects of oral and intravenous furosemide.
The FDA-approved Furoscix (furosemide injection) delivered via an On-body infusor is currently available and was approved for adult patients with edema in HF in 2022 and CKD in 2025. Furoscix ReadyFlow is expected to be commercially available in the United States by the end of August 2026, offering solutions for cardiologists, nephrologists, outpatient heart failure clinics and integrated delivery networks (IDN). The Furoscix ReadyFlow autoinjector will reduce administration time from five hours with the currently available On-body infusor to 10 seconds or less.
