Yet another FDA announcement from earlier this week…
The FDA has approved the inclusion of new data on onset and duration for Mannkind’s Afrezza prescribing information:
Full release with complete details of each of the highlighted items mentioned below:
Afrezza (insulin human) inhalation powder is approved by the FDA to improve glycemic control in adult patients with type 1 and type 2 diabetes mellitus. It is the only inhaled rapid-acting mealtime insulin available in the United States. Afrezza is dosed at the beginning of a meal and begins to appear in the blood in approximately one minute1.
Key highlights of the label update:
- 1) Inclusion of study data that describe the time-action profile by dosage strength, showing first measurable effect starts in approximately 12 minutes, peak effects occur approximately 35 to 45 minutes after dosing and return to baseline after approximately 1.5 to 3 hours for the 4 and 12 unit cartridges respectively.
- 2) Clarity on “Starting” and “Adjusting” mealtime dose.
- 3) Updated pregnancy and lactation section to conform to current FDA label guidance.