3rd time lucky? ScPharmaceuticals gets decision date for twice-rejected on-body drug delivery product

ScPharmaceuticals has an important new date for its calendar. With the FDA accepting an approval filing for its on-body infusor heart failure therapy, scPharmaceuticals is set to learn whether the candidate gets the green light to come to market by Oct. 8.

The new drug application covers Furoscix, a formulation of furosemide delivered via an on-body infusor for the treatment of congestion in patients with worsening heart failure. ScPharmaceuticals formulated furosemide solution to a neutral pH to allow for subcutaneous infusion via a wearable, preprogrammed on-body drug delivery system for self-administration in outpatient settings.

Massachusetts-based scPharmaceuticals previously sought approval for Furoscix in 2020, only for the FDA to hit it with a complete response letter over manufacturing issues and questions related to testing, labeling and features of the combination product. ScPharmaceuticals resubmitted its filing last month. 

The FDA’s acceptance of the application for review has given scPharmaceuticals an Oct. 8 PDUFA date, keeping it on track to hit its target of getting the product to market in the fourth quarter. Ahead of the FDA decision, scPharmaceuticals is preparing its for commercialization through activities such as physician, payer and pricing research and the finalization of its distribution partners. 

“We believe Furoscix, if approved, will address a significant need along the heart failure care continuum. By providing a new option for the treatment of congestion related to heart failure, all stakeholders—patients, payers and providers—stand to benefit, and there is the potential to generate significant healthcare system cost savings,” scPharmaceuticals CEO John Tucker said in a statement.

West Pharmaceutical Services is providing the delivery device, namely its second-generation SmartDose on-body, single-use drug delivery system that uses a prefilled cartridge.