MannKind Resubmits NDA For AFREZZA For Treatment Of Diabetes - Quick Facts

(RTTNews) - MannKind Corp. (MNKD) announced the resubmission on October 13, 2013 of a new drug application to the U.S. 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 company said the resubmission is based on the entire data set from the extensive AFREZZA clinical development program and particularly the positive results from two recent Phase 3 trials, one in patients with type 1 diabetes and one in patients with type 2 diabetes.

AFREZZA, a mealtime insulin therapy, consists 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.