MannKind Corporation (NASDAQ:MNKD) reported that the U.S. Food & Drug Administration has approved a revision to the Afrezza prescribing information to constitute new clinical data that was showcased at the 76th Scientific Sessions of American Diabetes Association in June 2016.
Afrezza inhalation powder is permitted by the FDA to enhance glycemic control in adults with type 2 and type 1 diabetes mellitus. It is the sole inhaled rapid-acting mealtime insulin offered in the United States. Afrezza is administered at the beginning of a meal and starts to appear in the blood in around one minute.
MannKind reported that there had to be inclusion of study data that highlight the time-action profile by prescription strength, demonstrating first measurable effect starts in around 12 minutes, peak effects happen around 35 to 45 minutes after being administered and return to baseline after around 1.5 to 3 hours for the 4 unit and 12 unit cartridges, respectively. There is clarity on “adjusting” and “starting” mealtime dose. The information should have updated lactation and pregnancy segment to conform to prevailing FDA label guidance.
Satish Garg, MD, MBBS, DM, the BDC, University of Colorado, expressed that this data articulates the fast-acting nature of Afrezza to resolve post-prandial hyperglycemia, distinguishing it from other mealtime alternatives available to assist patients maintain increased control over their blood glucose levels.
The basis of Clinical Pharmacology label change is an outcome of a controlled, randomized, six-treatment, crossover prescription-response trial assessing Afrezza to the fast-acting insulin analog, lispro, in thirty subjects with Type 1 diabetes.
Dosage and Administration information segment has been updated with step 1 to inform how subjects on injected mealtime insulin should preliminary be dosed on Afrezza. Additionally, step 2 was included to demonstrate that mealtime dose adjustments may be needed depending on the specific metabolic needs and glycemic control objectives.
The Pregnancy and Lactation segments of the label have been revised to conform to the prevailing FDA label guidance. These sections have been configured to offer healthcare providers with clearer risk benefit data for informed decision making in the respective populations.