The company also received additional IP protection for its investigational Furoscix ReadyFlow autoinjector. ReadyFlow remains under FDA review after the agency accepted a supplemental New Drug Application (sNDA) earlier this month.
For the on-body infusor, the FDA approved the company’s sNDA, expanding its indication to include pediatric patients weighing 43 kg or more. It previously had approval for treating edema associated with chronic heart failure (CHF) and chronic kidney disease (CKD) in adults.
MannKind says the additional approval fulfills all post-market requirements outlined in an initial approval letter under the Pediatric Research Equity Act.
“We are pleased to make FUROSCIX available to the pediatric population, a highly specific patient group, offering a convenient option outside the hospital setting for those who meet the weight criteria,” said Dr. Ajay Ahuja, chief medical officer of MannKind.
More on the MannKind autoinjector
Additionally, the company received five new U.S. patents for the ReadyFlow autoinjector. The patents cover the high-concentration liquid compositions of furosemide and associated methods of treatment, potentially through 2040.
MannKind said the patents create a robust IP portfolio designed to protect its formulation and delivery approach for years. If approved, the Furoscix ReadyFlow autoinjector would deliver an IV-equivalent diuretic dose in under 10 seconds. It would help patients with CHF or CKD manage fluid buildup episodes from the convenience of their own home.
“Furoscix ReadyFlow autoinjector has the potential to redefine how patients manage fluid overload episodes,” said Michael Castagna, MannKind CEO. “By delivering an IV-equivalent diuretic dose in seconds from the comfort of home, this innovation, if approved, could significantly reduce hospital visits, improve quality of life, and lower healthcare costs—creating meaningful value for patients, providers, and payers alike.”
MannKind picked up the Furoscix offerings through its August acquisition of scPharmaceuticals.
