MannKind Resubmits New Drug Application to FDA for AFREZZA for the Treatment of Adults with Diabetes

MannKind Corporation has announced the resubmission on 13 October 2013 of a new drug application (NDA) to FDA seeking approval for the marketing and sale of AFREZZA (insulin human [rDNA origin]) inhalation powder 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 extensive AFREZZA clinical development programme 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 FDA, and both achieved their primary efficacy endpoints and safety objectives,” said Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. “I am very proud of our team for completing an extensive submission on a very ambitious schedule. We will continue to work with FDA to bring AFREZZA to market for the millions of diabetes patients in the US who might benefit from this novel product.”

About AFREZZA

AFREZZA (uh-FREZZ-uh) is a novel, ultra rapid-acting mealtime insulin therapy developed by MannKind Corporation to improve glycemic control in adult patients with type 1 or type 2 diabetes. It is a drug–device combination product, consisting of AFREZZA Inhalation Powder delivered using a small, discreet and easy-to-use inhaler. Administered at the start of a meal, AFREZZA inhalation powder dissolves immediately upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12–15 min of administration, compared with 45–90 min for injected rapid acting insulin analogs and 90–150 min for injected regular human insulin.