MannKind Corporation (Nasdaq:MNKD) today 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™ (insulin human [rDNA origin]) Inhalation Powder for the
treatment of adult patients with type 1 and type 2 diabetes mellitus for
the control of hyperglycemia.
“We are currently reviewing the Complete Response letter and fully
expect that we will be able to respond to the FDA's requests in a timely
manner”
A Complete Response letter is issued by the FDA's Center for Drug
Evaluation and Research when the review of a file is completed and
questions remain that preclude the approval of the NDA in its current
form.
The Complete Response letter related to the AFREZZA application
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.