MannKind Announces FDA Approval of Afrezza®, the First and Only Inhaled Mealtime Insulin for Use in Children and Adolescents Aged 6 and Older Living with Diabetes
The FDA has approved Afrezza for use in children and adolescents aged 6 and older with type 1 and type 2 diabetes, expanding its label beyond adults. This approval is supported by the pivotal Phase 3 INHALE-1 study and over 20 years of safety data, introducing a needle-free, inhaled mealtime insulin option for pediatric patients.
Key figures
- Drug Name
- Afrezza
- Phase Of Trial
- Phase 3
- Monthly cost cap
- $35
- Pediatric population us
- 350,000
AI analysis
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.