FDA issues complete response letter for MannKind's Afrezza

VALENCIA, Calif. The Food and Drug Administration did not approve an application from MannKind Corp. for a drug to treat elevated blood sugar in diabetes patients, MannKind announced Monday.

The FDA gave the drug maker a complete response letter for Afrezza (insulin human [rDNA origin]) inhalation powder for adults with Type 1 and Type 2 diabetes. The FDA issues a complete response letter when it has completed review of an application, but still has questions that preclude approval in the application’s current form.

The FDA requested information and currently available clinical data to support the clinical utility of Afrezza and about the comparability of the commercial MedTone inhaler with the earlier version that was used in clinical trials. The FDA did not have any concerns about the drug’s safety, but it did ask for updated safety data while requesting changes to the drug’s labeling.

“We are currently reviewing the complete response letter and fully expect that we will be able to respond to the FDA’s requests in a timely manner,” MannKind chairman and CEO Alfred Mann said. “We had always planned to follow the original [application] for Afrezza with a regulatory submission for our next-generation inhaler rather than launch with the commercial version of the MedTone device.”

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