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news.FDA has accepted MannKind's resubmitted new drug application (NDA) for Afrezza (insulin human [rDNA origin]) and classified it as a Class 2 resubmission.
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Afrezza is a novel, ultra rapid acting mealtime insulin therapy being developed by MannKind for the treatment of adult patients with type 1 and type 2 diabetes for the control of hyperglycemia. It is a drug-device combination product, consisting of Afrezza inhalation powder pre-metered into single use dose cartridges and the light, discreet and easy-to-use Afrezza Inhaler.
In March 2010, MannKind received a complete response letter to its NDA for Afrezza from the FDA requesting additional information.
In response, MannKind has submitted clinical data from a recently completed efficacy study in patients with type 1 diabetes as well as updated pooled safety data related to Afrezza and information on the comparability of MannKind’s next-generation delivery system to the device that was used in pivotal clinical studies.
Alfred Mann, chairman and chief executive officer of MannKind, said: “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.
“We will continue to work closely with the FDA during this final stage of the review process. We firmly believe Afrezza can address a poorly-met need in diabetes therapy.”