MannKind (MNKD) said Friday the US Food and Drug Administration approved Afrezza, its inhaled mealtime insulin, for use in children and adolescents aged six and older with type 1 or type 2 diabetes.
The approval expands Afrezza's label beyond adults and was supported by results from the phase 3 INHALE-1 study and additional long-term safety and efficacy data, the company said.
MannKind said eligible patients can access Afrezza for $35 or less per month through its patient support program.
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