FDA Approves First Autoinjector for At-Home IV-Equivalent Diuresis

Today, the FDA has approved furosemide injection (Furoscix ReadyFlow; MannKind Corporation), the first and only autoinjector delivering subcutaneous furosemide with intravenous (IV)-equivalent exposure, for the treatment of edema in adults with heart failure (HF) or chronic kidney disease (CKD).¹ The approval expands the company's Furoscix franchise beyond its existing on-body infusor, which was approved for HF-related edema in 2022 and CKD-related edema in 2025.

“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, in a statement. “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.”

A Faster, At-Home Alternative

The furosemide autoinjector delivers a full 80 mg/mL dose of furosemide in a single administration in under 10 seconds, compared with the roughly 5-hour administration time required by the existing on-body infuser. IV-equivalent exposure was established through comparisons of area under the curve and pharmacodynamic endpoints, and the pivotal study also showed equivalent urine output and sodium and potassium excretion at 6, 8, and 12 hours relative to IV furosemide.

Symptom relief may begin within an hour of administration, and the therapy was generally well tolerated, with a safety profile consistent with known effects of oral and IV furosemide.^1,2

“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, in a statement.¹ “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 health care system.”

A Sizable and Growing Patient Population

HF affects approximately 6.7 million American adults, with prevalence projected to climb to 8.7 million by 2030, according to the Heart Failure Society of America.² CKD frequently coexists with HF and can further complicate fluid management, and HF remains among the costliest chronic conditions in the country, with hospitalizations driving roughly 80% of related health care spending.¹

The furosemide autoinjector is expected to be commercially available in the US by the end of August 2026.

Managed Care Implications

For payers and health systems, an at-home diuretic option with IV-equivalent exposure could shift a meaningful share of fluid-overload management out of the emergency department (ED) and away from inpatient admission, a cost driver that accounts for the majority of HF-related spending. Coverage and utilization decisions will likely hinge on how the autoinjector is positioned relative to oral diuretic step therapy and the existing on-body infusor, as well as how outpatient HF clinics, nephrology practices, and integrated delivery networks build referral and monitoring pathways around self-administered subcutaneous therapy. Payers may also want to track real-world readmission and ED-utilization data as the product reaches the market to assess whether reduced administration burden translates into measurable reductions in downstream acute care use.