FDA approves scPharmaceuticals' Furoscix sNDA for oedema in CKD
The US Food and Drug Administration (FDA) has approved scPharmaceuticals' supplemental new drug application (sNDA) for Furoscix(furosemide), expanding its indication to include oedema treatment in individuals with chronic kidney disease (CKD).
scPharmaceuticals is headquartered in Burlington in the US state of Massachusetts.
The Furoscix 80 mg/10 ml subcutaneous injection is intended for oedema in adult CKD patients, including those with nephrotic syndrome.
scPharmaceuticals CEO John Tucker stated: "We are thrilled to announce that the FDA has approved the sNDA for Furoscix, expanding the indication to include the treatment of oedema in patients with chronic kidney disease. This milestone marks a significant step forward for the Furoscix franchise and underscores our commitment to addressing the unmet needs of cardiorenal patients.
"In anticipation of this approval, we have taken strategic steps to ensure a successful launch, including key opinion leader engagement, comprehensive market research and commercial readiness initiatives.'
The therapy will be available for individuals with CKD in April 2025.
Furosemide's primary action is the inhibition of sodium and chloride reabsorption in the proximal and distal tubules and the loop of Henle. Its high diuretic effect is primarily due to its specific site of action. The effect on the distal tubule is not dependent on carbonic anhydrase or aldosterone's inhibitory effect.
The therapy is contraindicated in individuals with anuria or with a history of hypersensitivity to furosemide, any of its components or medical adhesives.
Clinical trials have identified common adverse events with Furoscix administration as site and skin reactions such as bruising, oedema, injection site pain and erythema.
"FDA approves scPharmaceuticals' Furoscix sNDA for oedema in CKD" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.
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