12.29.10
The FDA has informed MannKind Corporation that the agency will not be able to complete the review of the NDA for Afrezza (insulin human [rDNA origin]) Inhalation Powder by the action date of December 29, 2010. The FDA stated that it will require approximately four additional weeks to complete its review of the NDA.
Afrezza is a novel, ultra rapid acting mealtime insulin therapy being developed by MannKind for the treatment of adult patients with type 1 and type 2 diabetes for the control of hyperglycemia. It is a combination product, consisting of Afrezza Inhalation Powder pre-metered into single use dose cartridges and delivered via a small, discreet and easy-to-use Afrezza Inhaler.
Administered at the start of a meal, Afrezza dissolves immediately upon inhalation and delivers insulin quickly to the blood stream. Peak insulin levels are achieved within 12 to 14 minutes of administration, mimicking the early release of mealtime insulin observed in healthy individuals. To date, the Afrezza clinical program has involved more than 50 different studies and over 5,000 adult patients with both type 1 and type 2 diabetes.
Afrezza is a novel, ultra rapid acting mealtime insulin therapy being developed by MannKind for the treatment of adult patients with type 1 and type 2 diabetes for the control of hyperglycemia. It is a combination product, consisting of Afrezza Inhalation Powder pre-metered into single use dose cartridges and delivered via a small, discreet and easy-to-use Afrezza Inhaler.
Administered at the start of a meal, Afrezza dissolves immediately upon inhalation and delivers insulin quickly to the blood stream. Peak insulin levels are achieved within 12 to 14 minutes of administration, mimicking the early release of mealtime insulin observed in healthy individuals. To date, the Afrezza clinical program has involved more than 50 different studies and over 5,000 adult patients with both type 1 and type 2 diabetes.