Mannkind Corp resubmits NDA for Afrezza for T1&2D
Mannkind Corp has resubmitted its new drug application to the FDA seeking approval for Afrezza (insulin human [rDNA origin]) Inhalation Powder with an indication to improve glycemic control in adults with Type 1 or Type 2 Diabetes. The resubmission is based on the entire data set from the Afrezza clinical development program and particularly the positive results from two recent Phase III trials, one in patients with Type 1 Diabetes (study 171) and one in patients with Type 2 Diabetes (study 175).
This follows poor Phase III results in 2010, after which the FDA requested two further trials, with at least one trial including a group using the MedTone inhaler to get head-to-head comparison data.
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