FDA has sent MannKind Corp. a complete response letter regarding the company?s NDA for Afrezza Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes for the control of hyperglycemia.
FDA has sent MannKind Corp. a complete response letter regarding the company’s 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 for the control of hyperglycemia.
According to the letter, FDA is concerned about the usage of in vitro performance data and clinical pharmacology data to bridge MannKind’s next-generation inhaler to the phase 3 trials conducted using its MedTone inhaler. FDA requested that MannKind conduct 2 clinical trials with the next-generation inhaler (one in patients with type 1 diabetes and one in patients with type 2 diabetes), with at least 1 trial including a treatment group using the MedTone inhaler in order to obtain a head-to-head comparison of the data for the 2 devices. FDA stated that after an adequate titration of study medication there should be at least 12 weeks of relatively stable insulin dosing at the end of the treatment period.
FDA also requested additional information concerning the performance characteristics, usage, handling, shipment, and storage of the next-generation device; an update of safety information related to Afrezza; and information on proposed user training and changes to the proposed labeling of the device, blister pack, foil wrap, and cartons.
“While we are disappointed with the complete response letter, we are encouraged that FDA is asking for clinical studies only to confirm the bridging and handling of the next-generation device in order to compare it to the device used in our extensive clinical program,” said Alfred Mann, chairman and CEO of MannKind. “We remain committed to working with the FDA to make Afrezza available to people with diabetes.”