MannKind Corp.'s (MNKD) supplemental new drug application of FUROSCIX ReadyFlow Autoinjector for the treatment of edema in adults with chronic heart failure or chronic kidney disease has been accepted for review by the FDA, with a decision date set for July 26, 2026.
Edema, or fluid buildup, is a common and debilitating complication in CHF and CKD patients, often requiring hospital-based intravenous diuretic therapy.
The company's currently approved Furoscix is a subcutaneous formulation of the approved diuretic furosemide delivered via a wearable, pre-programmed, single-use, On-Body Infusor.
While the FUROSCIX On-Body Infusor will deliver a fixed dose of 80 mg of furosemide over about 5 hours, the ReadyFlow Autoinjector is designed to deliver an equivalent dose of FUROSCIX in under 10 seconds.
If approved, the FUROSCIX ReadyFlow Autoinjector would not only reduce administration time but also help reduce hospital admissions, ultimately lowering overall healthcare costs.
The sNDA submission is supported by positive study results announced in August 2024. In those trials, ReadyFlow demonstrated a bioavailability of 107.3%, meeting the FDA's confidence interval requirements of 80-125%. Patients using the autoinjector showed comparable urine output, sodium excretion, and potassium excretion to IV furosemide, with the therapy generally well tolerated and minimal injection site pain.
This marks a key milestone in expanding patient options and improving care", said Michael Castagna, PharmD, Chief Executive Officer of MannKind. "By delivering treatment in under 10 seconds, the ReadyFlow Autoinjector has the potential to empower patients with greater convenience and control in their treatment journey".
The company believes ReadyFlow could provide a cost-effective solution for managing fluid buildup episodes outside of hospital settings, benefiting patients, providers, and payors.
MNKD closed yesterday's trading session at $5.43, up 1.50%. Trading volume surged to about 26.6 million shares compared with an average volume of 4.2 million shares. Over the past 12 months, the stock has traded between $3.38 and $7.07.
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