MannKind Secures FDA Approval For Updated Afrezza Label Enhancing Dose Conversion Guidance

MannKind

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(RTTNews) - MannKind Corporation (MNKD) announced that the U.S. FDA has approved an update to the Afrezza prescribing information, adding new guidance for determining the starting mealtime dose when switching patients from multiple daily injections or insulin pump bolus therapy.

Afrezza, an ultra-rapid-acting inhaled insulin delivered via MannKind's Technosphere platform is already approved for adults with diabetes in the United States, India, and Brazil. It remains the only inhaled mealtime insulin currently available in the U.S. market.

The newly approved label revision incorporates a conversion table and dosing recommendations supported by modeling analyses and clinical data from the Dose Optimization and INHALE-3 studies.

According to MannKind, the updated guidance is intended to give healthcare providers clearer, evidence-based direction when initiating Afrezza in patients switching from injected rapid-acting insulin.

The company stated that the revised prescribing information will be integrated into Afrezza packaging and educational materials, with updated resources expected to become available in the coming weeks.

MannKind also noted that it will continue working with clinicians and diabetes care teams to support adoption of the new dosing framework. Afrezza remains the only inhaled mealtime insulin available in the U.S. market, and MannKind continues to advance additional clinical initiatives aimed at expanding its use across broader patient populations.

In addition to the updated adult label, the FDA has accepted for review a sBLA seeking to expand Afrezza's use to children and adolescents aged 4-17 years living with type 1 or type 2 diabetes.

The application carries a PDUFA target action date of May 29, 2026.

The sBLA is supported by results from the Phase 3 INHALE-1 study, a 26-week open-label, randomized trial evaluating Afrezza plus basal insulin versus multiple daily injections (MDI) with basal insulin in children and adolescents with type 1 and type 2 diabetes.

Afrezza generated $18.5 million in Q3 2025, up from $15.0 million in the prior-year quarter, representing a 23% increase, all of which reflects adult commercial use.

MNKD has traded between $3.38 and $6.51 over the past year. The stock is currently trading in the pre-market at $5.73, up 4.95%.