MannKind Corporation announced that it was informed on December 27, 2010 by the US Food & Drug Administration (FDA) that the agency will not be able to complete the review of the New Drug Application (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 Corporation 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.
MannKind Corporation focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer. Its diabetes pipeline includes Afrezza and MKC253. MannKind has submitted a NDA to the FDA requesting approval of Afrezza for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycemia. MKC253 is currently in phase I clinical trials. Other products in MannKind's pipeline include the cancer immunotherapy platform MKC1106, which is currently in phase II clinical trials.