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FDA updates prescribing information for Afrezza
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The FDA recently approved updated prescribing information for the only available inhaled insulin powder to include new clinical data that was presented at the American Diabetes Associations’ Scientific Sessions in 2016, according to a release from MannKind Corporation.
The inhaled rapid-acting mealtime insulin (Afrezza, MannKind) is approved to improve glycemic control in adults with type 1 and type 2 diabetes.
Updates to the prescribing information include the following:
- Inclusion of data describing the time-action profile by dosage strength;
- Clarity for “starting” and “adjusting” mealtime dose;
- And an updated pregnancy and lactation section to adhere to current FDA-level guidance.
“These data articulate the rapid-acting nature of Afrezza to address postprandial hypgerglycemia, setting it apart from other mealtime options available to help patients maintain greater control over their blood glucose levels,” Satish Garg, MD, MBBS, DM, of the Barbara Davis Center for Diabetes at the University of Colorado, said in the release.
“Available data suggest approximately 70% of people living with diabetes on insulin are not at HbA1c goals of less than 7%,” Michael Castagna, chief executive officer of MannKind Corporation, said. “We firmly believe that in order for patients to achieve better HbA1c goals, control of mealtime glucose spikes is critical. This label update supports Afrezza as a unique fast-acting mealtime insulin that provides doctors and patients with the flexibility necessary to help them achieve glycemic control.”
The inhaled insulin was approved in 2014 and became available in the United States in 2015.