MannKind Insulin Drug Approval Gets Further Delay

The U.S. Food & Drug Administration has delayed its approval decision for MannKind Corp.’s application for its new diabetes drug due to further questions about clinical data, MannKind received a “complete response letter” from the federal agency, which requests more information before an approval decision on AFREZZA Inhalation Powder can be made. The company had already experienced a delay in its drug approval when it had to resubmit its application last year, which was also due to a request by the agency for more information. The drug is designed for the treatment of adult patients with Type 1 and Type 2 diabetes for the control of hyperglycemia. The principal issue the FDA raised concerned the usage of in vitro performance data and clinical pharmacology data to bridge the company’s next generation inhaler to the phase-three trials conducting using its MedTone inhaler. The agency has requested that the company conduct two clinical trials with the next-generation inhaler, with at least one trial including a treatment group using the MedTone inhaler in order to obtain a head-to-head comparison of the data for the two devices. The agency added that there should also be at least 12 weeks of relatively stable insulin dosing at the end of the treatment period. The agency has also requested additional information concerning the performance characteristics, usage, handling, shipment and storage of the next-generation device and an update of safety information related to AFREZZA. Another request was for 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 the 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, the company’s chairman and CEO. “We remain committed to working with the FDA to make AFREZZA available to people with diabetes.” The company has already started a series of studies of the next-generation device in patients with Type 1 and Type 2 diabetes, Mann said. Jessica Vernabe