scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the FUROSCIX® Indication to Include the Treatment of Edema in Patients with Chronic Kidney Disease

Core Viewpoint - The FDA has approved scPharmaceuticals' supplemental New Drug Application (sNDA) for FUROSCIX, expanding its indication to treat edema in adult patients with chronic kidney disease (CKD), including nephrotic syndrome, with availability expected in April 2025 [1][2]. Company Overview - scPharmaceuticals is focused on revolutionizing cardiorenal healthcare through patient-centric innovations and aims to address unmet needs in the cardiorenal patient population [1][11]. - The company has taken strategic steps to ensure a successful launch of FUROSCIX, including engaging key opinion leaders, conducting comprehensive market research, and preparing for commercial readiness [2]. Product Information - FUROSCIX® (furosemide injection) is indicated for the treatment of edema in adult patients with chronic heart failure or CKD, including nephrotic syndrome [3]. - The product is expected to provide clinicians with an additional tool for managing fluid overload in CKD patients, potentially allowing them to keep patients at home while restoring and maintaining euvolemia [2]. Safety Information - FUROSCIX is contraindicated in patients with anuria and those with a history of hypersensitivity to furosemide or its components [4]. - Common adverse reactions include site and skin reactions such as erythema, bruising, edema, and injection site pain [10].