FDA has sent MannKind Corp. a complete response letter regarding the company?s New Drug Application for Afrezza (insulin human [rDNA origin]) Inhalation Powder for the treatment of adult patients with types 1 and 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 types 1 and 2 diabetes for the control of hyperglycemia.
A complete response letter is issued by FDA’s Center for Drug Evaluation and Research when the review of a file is completed but questions remain that preclude the approval of the NDA in its current form.
According to the letter, FDA is concerned about the use 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 has requested that MannKind conduct 2 clinical trials with the next-generation inhaler (1 in patients with type 1 diabetes and 1 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.”