Positive Type C meeting feedback from FDA on potential heart failure class IV indication expansion of Furoscix
scPharmaceuticals Inc. a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs announced that the Company has received positive Type C meeting feedback from the FDA regarding the potential expansion of the Furoscix indication to allow for use in New York Heart Association (NYHA) Class IV heart failure patients
Furopscix is currently indicated for the treatment of congestion due to fluid overload in adult patients with NYHA Class II and Cx ass III chronic heart failure.
“We are very pleased with the outcome of our recent Type C meeting with the FDA, and believe this paves the way for potential expansion of the Furoscix indication to allow for use in NYHA Class IV patients,” stated John Tucker, Chief Executive Officer of scPharmaceuticals. “We estimate that as many as 10% of all heart failure patients are Class IV, and a meaningful percentage of these – as many as 40% - may benefit from Furoscix. To that end, we plan to file for Class IV indication expansion by the end of this year.”
The Company also announced the issuance of U.S. patents covering concentrated formulations of furosemide. This enables the possibility of developing additional furosemide formulations for subcutaneous administration that will provide clinicians with additional dosing flexibility.
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