regulatory
confidence high
sentiment positive
materiality 0.75
FDA approves Afrezza for pediatric diabetes patients ages 6+
MANNKIND CORP
- FDA approved supplemental BLA for Afrezza (insulin human) Inhalation Powder for children and adolescents aged 6 and older with type 1 and type 2 diabetes.
- More than 350,000 U.S. children and adolescents live with diabetes; majority have type 1 and require lifelong insulin.
- Approval fulfills the last postmarketing requirement from the original June 27, 2014 approval letter.
- MannKind expects to expand the patient population for Afrezza beyond adults.