FDA rejects approval of MannKind's Afrezza, requests additional trials

MannKind on Wednesday reported that it received a complete response letter from US regulators regarding its application to market its inhaled insulin Afrezza for patients with type 1 and type 2 diabetes. The FDA requested that the company conduct two additional clinical trials with MannKind's next generation inhaler, instead of the MedTone inhaler used in previous late-stage studies of the drug.

The agency also requested additional information regarding the "performance characteristics, usage, handling, shipment and storage of the next-generation device, an update of safety information related to Afrezza, as well as information on proposed user training and changes to the proposed labeling of the device," the company said.

Commenting on the news, CEO Alfred Mann noted that "we have already begun a series of studies of the next-generation device in patients with type 1 (Affinity 1) and type 2 (Affinity 2) diabetes." The executive added that the company plans "to meet with the agency as quickly as possible in order to be confident that these trials, with appropriate modifications to incorporate a comparison to the MedTone device, will suffice in addressing the agency's questions about patient use and robustness of the next-generation device."

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