MannKind Corporation announced that the FDA has accepted the company’s sBLA for the use of Afrezza inhaled dry powder insulin in diabetes patients aged 4 to 17 and has set a PDUFA date of May 29, 2026. Afrezza has been approved in the US for the treatment of Type 1 and Type 2 diabetes in adults since 2014. In August 2025, MannKind announced that it had secured financing to support commercialization of the inhaler for pediatric use if the sBLA is approved.
The company says that the application was supported by data from the Phase 3 INHALE-1 trial of Afrezza in pediatric patients, including data from the extension phase that was not included in the results released in December 2024.
MannKind Senior VP, Therapeutic Area Head, Endocrine Diseases, Kevin Kaiserman commented, “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. 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.”
Read the MannKind Corporation press release
