MannKind receives FDA approval for Afrezza dosage label

MannKind (MNKD) announced that the FDA has approved an update to the Prescribing Information for Afrezza – insulin human – Inhalation Powder, revising recommendations for the starting mealtime dosage when patients switch from subcutaneous mealtime insulin regimens. The updated labeling was supported by modeling data and in vivo results from the Dose Optimization study and the INHALE-3 trial that demonstrated improved postprandial glucose outcomes following conversion to inhaled insulin using the now-approved conversion dose. The revised dosing recommendations, provided in the table below, include recommended dose conversions from injected mealtime insulin or insulin pump bolus dosing to the appropriate mealtime dosage of Afrezza and are intended to support a clinically appropriate and safe transition for adult patients initiating Afrezza.