MannKind Corporation has resubmitted a new drug application (NDA) to the U.S. Food and Drug Administration (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. Concerned about usage of in vitro performance data and clinical pharmacology data to bridge MannKind’s next-generation inhaler to the phase 3 trials conducted using its MedTone inhaler, the FDA rejected the original NDA in January 2011. The FDA requested that MannKind conduct two clinical trials with the next-generation inhaler (one in patients with type 1 diabetes and one in patients with type 2 diabetes), with at least one trial including a treatment group using the MedTone inhaler in order to obtain a head-to-head comparison of the data for the two devices.
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 (study 171) and one in patients with type 2 diabetes (study 175) conducted by MannKind following the FDA request.
AFREZZA 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 to 15 minutes of administration, compared to 45-90 minutes for injected rapid acting insulin analogs and 90-150 minutes for injected regular human insulin.