According to MannKind Corporation, the company resubmitted its new drug application for Afrezza insulin inhalation powder for the treatment of type 1 and type 2 diabetes to the FDA on October 13, 2013. The resubmitted application includes all data from the product’s clinical development program, the company said. Earlier this year, MannKind announced positive results from Phase 3 studies in patients with type 1 diabetes and in patients with type 2 diabetes.
MannKind Chairman and CEO Alfred Mann commented, “We 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.”
Read the MannKind press release.
