MannKind Confirms Design of Pivotal Studies

MannKind MNKD today announced that it has confirmed with the U.S. Food and Drug Administration the design of two clinical studies that evaluate the efficacy and safety of AFREZZA, an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind's next-generation inhaler. The FDA had previously requested that MannKind conduct two 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 one trial including a treatment group using the previously studied MedTone inhaler in order to obtain a head-to-head comparison of the pulmonary safety data for the two devices. Hakan Edstrom, President and Chief Operating Officer, reported that, “We held a successful meeting with the FDA yesterday, confirming the protocols for the type 1 and type 2 studies. We were also encouraged to proceed promptly with the initiation of both clinical trials.”