MannKind Corp. has resubmitted the NDA for Afrezza (insulin human [rDNA origin]) Inhalation Powder to the FDA. The NDA seeks approval for the marketing and sale of Afrezza with an indication to improve glycemic control in adults with type 1 or type 2 diabetes.

The resubmission is based on the entire data set from the Afrezza clinical development program and particularly the positive results from two recent Phase III trials, one in patients with type 1 diabetes (study 171) and one in patients with type 2 diabetes (study 175).

“We designed the recent studies with input and guidance from the FDA, and both achieved their primary efficacy endpoints and safety objectives,” said Alfred Mann, chairman and chief executive officer of MannKind. “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.”