US-based biopharmaceutical company MannKind has resubmitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking marketing authorization for its AFREZZA inhalation powder, indicated to improve glycemic control in adults with type 1 or type 2 diabetes.
AFREZZA (insulin human [rDNA origin]) is an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind's next-generation inhaler.
AFREZZA was studied in patients with type 1 diabetes (study 171) in one Phase III clinical trial and the drug was studied in patients with type 2 diabetes (study 175) in the other Phase III clinical trial.
Based on the positive results from the two recent Phase III clinical trials assessing the safety of AFREZZA, the company has now again filed for marketing authorization of the inhaled diabetes drug.
MannKind chairman and CEO Alfred Mann noted the company designed the recent studies with input and guidance from the FDA, and both achieved their primary efficacy endpoints and safety objectives.
"I am very proud of our team for completing an extensive submission on a very ambitious schedule. We will continue to work with the FDA to bring AFREZZA to market for the millions of diabetes patients in the United States who might benefit from this novel product," Mann added.
In January 2011, the FDA had rejected AFREZZA and advised MannKind to conduct two clinical trials with the next-generation inhaler, one in patients with type 1 diabetes and one in patients with type 2 diabetes.
The FDA also suggested MannKind to provide additional information concerning the performance characteristics, usage, handling, shipment and storage of the next-generation device.
In June 2011, the company announced that the findings of two separate studies further substantiated that treatment with the investigational ultra rapid acting mealtime insulin AFREZZA inhalation powder does not result in excess cardiovascular events in type 1 or type 2 diabetes patients.
In addition, the results have shown that inhaled AFREZZA did not produce clinically significant effects on heart rate, PR and QRS interval duration, or cardiac morphology.
In October 2012, MannKind completed patient enrollment for two Phase III clinical studies of AFREZZA.