NEWS
scPharmaceuticals Announces Filing Acceptance of Supplemental New Drug Application (sNDA) Seeking to Expand FUROSCIX Indication to Include Chronic Kidney Disease
scPharmaceuticals Inc. (Nasdaq: SCPH)announced that the FDA has accepted their Supplemental New Drug Application (sNDA) to expand FUROSCIXindication to include treatment of edema due to fluid overload in patients with chronic kidney disease (CKD). The FDA has set a PDUFA target action date of March 6, 2025.
Key points:
No additional clinical studies needed for indication expansion
CKD affects more than 1 in 7 U.S. adults
Estimated $3 billion addressable market
Company preparing to deploy additional commercial resources if sNDA is approved
FUROSCIX is currently indicated for treating congestion due to fluid overload in adult patients with NYHA Class II and III chronic heart failure.
Key points:
No additional clinical studies needed for indication expansion
CKD affects more than 1 in 7 U.S. adults
Estimated $3 billion addressable market
Company preparing to deploy additional commercial resources if sNDA is approved
FUROSCIX is currently indicated for treating congestion due to fluid overload in adult patients with NYHA Class II and III chronic heart failure.
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