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FDA Requests Additional Information Regarding Afrezza
A Complete Response letter is issued by the FDA's Center for Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form.
The Complete Response letter related to the Afrezza application requested several items, including information and currently available clinical data that support the clinical utility of Afrezza and information about the comparability of the commercial version of the MedTone inhaler to the earlier version of this device that was used in pivotal clinical trials. The letter cited no safety concerns, but requested updated safety data related to Afrezza. The letter also requested changes to the proposed labeling of the cartridges, foil pouches and cartons.
The letter did not require any additional pre-marketing clinical studies in order for the FDA to complete its review of the NDA. As recommended by the FDA, MannKind will request an End-of-Review meeting with the agency to discuss its approach for resolving the remaining issues.
"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," said Alfred Mann, Chairman and Chief Executive Officer. "We had always planned to follow the original NDA for Afrezza with a regulatory submission for our next-generation inhaler rather than launch with the commercial version of the MedTone device. We will discuss with the FDA whether it is appropriate to use what would otherwise have been a supplemental NDA submission, which we had planned to make during the second quarter of this year, to address the agency's requests. If this approach is acceptable, we believe that this regulatory action will not have a significant impact on the timing of the commercial launch of Afrezza. We will work closely with the FDA to answer quickly the agency's questions and satisfy the requirements. We are committed to working with the FDA to make Afrezza available to patients as soon as possible."
Afrezza(TM) (insulin human [rDNA origin]) Inhalation Powder is a novel, ultra rapid acting mealtime insulin therapy being studied for use in adult patients with type 1 and type 2 diabetes mellitus for the treatment of hyperglycemia. Afrezza is a drug-device combination product, consisting of Afrezza Inhalation Powder pre-metered into single use dose cartridges and a light, discreet and easy-to-use Afrezza Inhaler. Administered at the start of a meal, Afrezza dissolves immediately upon inhalation and delivers insulin quickly to the blood stream. Peak insulin levels are achieved within 12 to 14 minutes of administration, effectively mimicking the release of meal-time insulin observed in healthy individuals. The Afrezza clinical program included over 5,000 adult patients.
Source: MannKind Corporation