You are here
Diabetes Drug Afrezza (Insulin Inhalation Powder) Resubmitted for FDA Review
A new drug application (NDA) has been resubmitted to the FDA seeking approval for the marketing and sale of Afrezza (insulin human [rDNA origin]) inhalation powder (Mannkind Corp.) with an indication to improve glycemic control in adults with type 1 or type 2 diabetes.
The resubmission was based on the entire data set from the Afrezza clinical development program, particularly the positive results from two recent phase III trials — one in patients with type 1 diabetes and one in patients with type 2 diabetes.
Afrezza is an investigational rapid-acting mealtime insulin therapy designed 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 via a small, 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 after administration, compared with 45 to 90 minutes for injected rapid-acting insulin analogs and 90 to 150 minutes for injected regular human insulin.
Source: Mannkind Corp.; October 14, 2013.