Mannkind: FDA Advisory Committe votes in favor of safety and efficacy of AFREZZA for the treatment of both type 1 and type 2 diabetes (stock halted) (4.02 0.00)
The Endocrinologic and Metabolic Drugs Advisory Committee recently concluded it's review of new drug application (NDA) 22-472, proposed trade name AFREZZA (TECHNOSPHERE Insulin Inhalation System), 3 unit and 6 unit cartridges for oral inhalation, manufactured by MannKind Corporation. The proposed indication (use) for this application is to improve glycemic control in adult patients with type 1 or type 2 diabetes mellitus.
The panel voted 13 yes, 1 no, with 1 abstain in favor of the safety and efficacy of AFREZZA for the treatment of type 1 diabetes.
The panel voted 14 yes, 0 no in favor of the safety and efficacy of AFREZZA for the treatment of type 2 diabetes.
--> Co confirmed that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted 13 to 1 to recommend that AFREZZA (insulin human [rDNA origin]) Inhalation Powder be granted marketing approval by the FDA to improve glycemic control in adults with type 1 diabetes and voted 14 to 0 to recommend that AFREZZA be granted marketing approval by the FDA to improve glycemic control in adults with type 2 diabetes. If approved, AFREZZA would be the first ultra rapid-acting mealtime insulin therapy available in the United States.