FDA Approves scPharmaceuticals’ Furoscix for Chronic Heart Failure Congestion

The FDA has approved scPharmaceuticals’ Furoscix (furosemide injection) for treatment of congestion due to fluid overload in adults with chronic heart failure.

The drug is a subcutaneous diuretic self-administered at home by the patient or a caregiver with the use of the company’s On-Body Infusor developed using West Pharmaceutical Services’ proprietary SmartDose delivery technology.

The agency approval was supported by data from a clinical study that established the equivalence of subcutaneous and intravenous delivery of the drug.

The FDA had twice declined to approve the product. In June 2018, the agency cited the need for additional human factors studies, device modifications and potentially a clinical validation study. The agency again refused approval in December 2020, citing deficiencies at a third-party production facility.

Furoscix is specifically indicated for treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure. The drug is not indicated for use in emergency situations or in patients with acute pulmonary edema, the company said.

A commercial launch is planned in the first quarter of 2023.