scPharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for FUROSCIX®.
FUROSCIX® is designed to support the management of oedema by restoring and maintaining fluid balance, potentially reducing the need for hospitalisation. The company aims to introduce the treatment to nephrologists and other healthcare providers to enhance patient care.
Chronic Kidney Disease (CKD) is a long-term condition where the kidneys gradually lose their ability to function properly. It is characterised by a decline in kidney function over time, leading to the accumulation of waste and excess fluids in the body. CKD is often caused by conditions such as diabetes, high blood pressure, and glomerulonephritis.
Symptoms may not appear in the early stages but can include fatigue, swelling (oedema), high blood pressure, and changes in urination. If left untreated, CKD can progress to kidney failure, requiring dialysis or a kidney transplant.
This approval expands the drug’s indication to include the treatment of oedema in adult patients with chronic kidney disease (CKD).
The expanded approval allows FUROSCIX®, an 80 mg/10 mL furosemide injection for subcutaneous use, to be used for managing fluid overload in patients with CKD, in addition to those with chronic heart failure.
This decision is expected to provide an additional treatment option for healthcare professionals managing oedema in these patient groups.
The expansion is intended to help address the medical needs of patients with heart failure and CKD who experience acute fluid overload.
Ahead of the approval, the company has taken steps to support a smooth launch, including engaging with key experts, conducting market research, and implementing commercial readiness plans.