MannKind announces U.S. FDA accepted sBLA for Afrezza Inhalation Powder

MannKind (MNKD) announced that the U.S. Food and Drug Administration, FDA, has accepted the supplemental biologics license application, sBLA, seeking approval for Afrezza Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes. The application has been assigned a Prescription Drug User Fee Act, PDUFA, target action date of May 29, 2026. “Today’s milestone brings us one step closer to offering young children and teenagers living with diabetes a potential alternative therapy to multiple daily injections or an insulin pump system,” said Dr. Kevin Kaiserman, M.D., Senior Vice President, Therapeutic Area Head, Endocrine Diseases at MannKind Corporation. “Inhaled insulin has been available to adults for over a decade, and we are excited about the potential of adding this treatment choice for the pediatric population.”