MannKind (MNKD) shares jumped about 10% in afternoon trading after the pharmaceutical company announced the Food and Drug Administration accepted its resubmission of its inhaled insulin, Afrezza. The FDA set a review date for Dec. 29.
Afrezza is an ultra-rapid acting mealtime insulin therapy to control hyperglycemia for adult patients with type 1 and type 2 diabetes. The drug-device combination product consists of Afrezza Inhalation Powder pre-metered into single-use dose cartridges and the Afrezza Inhaler.
In March, after a few months of delay, MannKind received a complete response letter from the FDA requesting additional information on Afrezza. MannKind, in response, submitted clinical data from a recently completed study in patients with type 1 diabetes, as well as updated pooled safety data related to the drug. It also submitted information on the comparability of MannKind's next-generation delivery system to the device that was used in pivotal clinical studies.
"We have worked diligently since March to prepare our resubmission and we are confident that we have addressed the requests that were outlined by the FDA," said Alfred Mann, chairman and CEO.
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