MannKind's (MNKD) Furoscix ReadyFlow injection has been approved by the US Food and Drug Administration for the treatment of edema, or fluid overload, in adults with heart failure or chronic kidney disease, the company said Friday.
The at-home treatment option allows adults with heart failure or kidney disease to remediate fluid overload before symptoms lead to emergencies or hospitalization, the company said.
The approval is backed by clinical data showing that Furoscix ReadyFlow achieved its primary endpoint, the company said.
The autoinjector version reduces administration time to 10 seconds or less from five hours with the currently available infusor, the company said.
Shares of the company were up 6.7% in recent premarket activity.