Overview
- The FDA cleared Afrezza for children and adolescents aged six and older, and MannKind said the product is now available for eligible pediatric patients.
- The decision was supported by the Phase 3 INHALE-1 trial, which found inhaled Afrezza produced similar blood‑sugar control to injected rapid‑acting insulin with less weight gain and higher treatment satisfaction.
- Prescribing guidance warns that Afrezza is not for people who smoke or who have chronic lung disease, and it requires baseline and ongoing lung‑function testing because of risks such as decreased lung function and a possible lung‑cancer signal.
- MannKind announced an access program that can reduce patient costs to $35 or less per month for eligible families and said it will offer support services through MannKind Cares to help with coverage and training.
- Clinicians face practical steps for rollout, including converting injected doses to inhaled units, training patients and caregivers on the inhaler, and staging prescriptions as providers adopt the new pediatric indication.