FDA at last approves Furoscix

In what could be a paradigm shift in the treatment of congestion due to worsening heart failure, the US Food and Drug Administration (FDA) has approved Furoscix (furosemide injection), a proprietary formulation of furosemide delivered via an On-Body Infusor for the treatment of congestion due to fluid overload in adults with New York Heart Association Class II/III chronic heart failure.

Developed by scPharmaceuticals (Nasdaq: SCPH), Furoscix is the first and only FDA-approved subcutaneous loop diuretic that delivers IV equivalent diuresis at home via the Furoscix Infusor. News of the approval pushed the firm’s shares up 7% to $5.19 in early pre-market trading, but they later slipped back.

scPharmaceuticals previously filed approval for Furoscix in 2020, but the FDA issued a complete response letter over manufacturing issues and questions related to testing, labeling and features of the combination product. ScPharmaceuticals resubmitted its New Drug Application (NDA) in April this year, following which the regulator set a Prescription Drug User-Fee Act (PDUFA) target action date of October 8, 2022.