MannKind Corporation announced that it has received a Complete Response letter from the U.S. Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for AFREZZA(TM) Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes.
The Complete Response letter requested several items, including information and currently available clinical data that support the clinical utility of AFREZZA, and information about the comparability of the commercial version of the MedTone inhaler to the earlier version of this device that was used in pivotal clinical trials. The letter cited no safety concerns, but requested updated safety data related to AFREZZA. The letter also requested changes to the proposed labeling of the cartridges, foil pouches and cartons.
The letter did not require any additional pre-marketing clinical studies in order for the FDA to complete its review of the NDA. As recommended by the FDA, MannKind will request an End-of-Review meeting with the agency to discuss its approach for resolving the remaining issues.