MannKind Corporation announced that the FDA has approved the company’s sBLA for use of Afrezza inhaled dry powder insulin for the treatment of Type 1 and Type 2 diabetes in children aged 6 and older. Afrezza was initially approved by the FDA for the treatment of Type 1 and Type 2 diabetes in adults in 2014. In October 2025, the company announced that the agency had accepted an sBLA for the use of Afrezza in Type 1 and Type 2 diabetes patients aged 4 to 17.
According to MannKind, the application was supported by data from the Phase 3 INHALE-1 trial of Afrezza in pediatric patients. Earlier this year, the company initiated the Phase 2 INHALE-1ST trial of Afrezza in children aged 10 with a recent Type 1 diabetes diagnosis.
MannKind CEO Michael Castagna commented, “For more than a century, insulin therapy for children living with diabetes has largely meant multiple daily injections. Children and their families deserve new treatment options that fit the realities of daily life. Afrezza allows dosing at the moment of eating, without the need for pre-meal planning, making it a practical option for unplanned meals and snacks on the go. Our founder, Al Mann, would be proud of the dedication and teamwork that made it possible to bring this novel innovation to children and families.”
Read the MannKind Corporation press release
