This at-home treatment option aims to address fluid overload early, potentially reducing the need for emergency department visits, hospitalizations, or readmissions.
The FDA’s decision was based on positive clinical data showing that Furoscix ReadyFlow met its primary pharmacokinetic endpoint and was generally well tolerated, with a safety profile similar to oral and intravenous furosemide.
Heart failure currently affects about 6.7 million adults in the United States, a number expected to rise to over 8 million by 2030.
Fluid overload is a major factor in worsening symptoms and a common cause for emergency medical interventions in patients with heart failure or chronic kidney disease.
“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.
