MannKind (Nasdaq:MNKD) announced that the FDA accepted a supplemental New Drug Application (sNDA) for its Furoscix ReadyFlow autoinjector.
The Furoscix ReadyFlow autoinjector (SCP-111) was developed to deliver a subcutaneous furosemide injection as an investigational alternative to the FDA-approved Furoscix on-body infusion device for treating edema in adult patients with chronic heart failure (CHF) or chronic kidney disease.
In August, MannKind acquired scPharmaceuticals, adding the company’s edema therapeutic offering to its portfolio to expand into cardiorenal medicine. Furosemide currently serves as the standard for treating fluid overload in adult patients with chronic heart CHF and CKD.
Now, the company says its ReadyFlow autoinjector would provide a new option for those patients. It would enable them to manage fluid buildup episodes from the convenience of their own home, rather than in a hospital setting. The autoinjector could reduce administration time from five hours to less than 10 seconds, according to a news release.
MannKind supported its sNDA with positive study results announced in August 2024. The application has a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2026.
“The Furoscix ReadyFlow Autoinjector marks a key milestone in expanding patient options and improving care. 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,” said Michael Castagna, CEO at MannKind Corporation. “We are excited about the opportunity to bring this innovation forward and empower patients with greater convenience and control in their treatment journey.”
The Furoscix advancements come as MannKind also looks to continue advancing its inhaled insulin product.
