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Pediatrics

MannKind Corporation's Afrezza Receives FDA Approval sBLA for Pediatric Patients

Strategic Insights

— 1 min read

The U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) from MannKind Corporation for Afrezza (insulin human) 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. The decision is based on the results of the Phase 3 INHALE-1 study, which evaluated Afrezza in combination with basal insulin versus multiple daily injections (MDI) with basal insulin in children and adolescents between the ages of 4-17.

Key Takeaways:

  • The FDA has accepted the sBLA for Afrezza in pediatric patients, setting a PDUFA target action date of May 29, 2026.
  • The application is based on the results of the Phase 3 INHALE-1 study, which evaluated Afrezza in combination with basal insulin versus MDI with basal insulin in children and adolescents between the ages of 4-17.
  • Six-month topline results from INHALE-1 were reported in December 2024, and the submission also included safety data from the study's 26-week extension phase.
  • Afrezza was first approved by the FDA for adults (age 18+) in June 2014 and is also approved in India and Brazil.
  • The treatment is recognized as part of the American Diabetes Association's Standards of Care.
  • The most common adverse reactions are hypoglycemia, cough, and throat pain or irritation.
  • Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD.
  • MannKind Corporation aims to deliver therapies designed to fit seamlessly into daily life and is dedicates to transforming chronic disease care through innovative, patient-centric solutions.

Statistics:

  • The sBLA has been assigned a PDUFA target action date of May 29, 2026.
  • The Phase 3 INHALE-1 study included children and adolescents between the ages of 4-17.
  • Six-month topline results from INHALE-1 were reported in December 2024.
  • Afrezza was first approved by the FDA for adults (age 18+) in June 2014.
  • The American Diabetes Association's Standards of Care recognize Afrezza as a treatment option.

Sources:

  • GlobeNewswire, MannKind Corporation, "MannKind Announces FDA Acceptance of Supplemental Biologics License Application (sBLA) for Afrezza (insulin human) Inhalation Powder in Pediatric Patients" (October 13, 2025)
  • MannKind Corporation, "About Afrezza"
  • MannKind Corporation, "About MannKind Corporation"

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