MannKind says FDA accepts for review its sNDA of of FUROSCIX ReadyFlow

The company states: “MannKind (MNKD) announced that the FDA has accepted the sNDA seeking approval for FUROSCIX ReadyFlow Autoinjector, developed to deliver a subcutaneous furosemide injection in under 10 seconds as an investigational alternative to the FDA-approved FUROSCIX(R) (furosemide) On-body Infusor for treatment of edema in adult patients with chronic heart failure or chronic kidney disease. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2026. If approved, FUROSCIX ReadyFlow Autoinjector would provide a new option for patients with CHF or CKD to manage fluid buildup episodes from the convenience of their home rather than in a hospital setting. The FDA-approved FUROSCIX On-body Infusor was approved for adult patients with edema in chronic heart failure in 2022 and in chronic kidney disease in 2025. The ReadyFlow Autoinjector would reduce administration time from five hours to under 10 seconds. The sNDA is supported by positive study results announced in August 2024. Furosemide via the ReadyFlow Autoinjector demonstrated a bioavailability of 107.3% (90% CI: 103.9 – 110.8), achieving the 90% confidence interval limit of 80 to 125 percent. Additionally, participants who utilized ReadyFlow Autoinjector had similar urine output, urinary sodium excretion and urinary potassium excretion at 6, 8, and 12 hours compared to IV furosemide, and was generally well tolerated with respect to injection site pain.”