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MannKind inhaled insulin delayed again

The US Food and Drug Administration has declined for a second time to approve the new drug application for MannKind's inhaled insulin product Afrezza

The US Food and Drug Administration (FDA) has declined for a second time to approve the new drug application for MannKind's inhaled insulin product Afrezza, requesting two additional clinical trials for the product.

Afrezza is a rapid-acting drug-device combination product intended to control hyperglycaemia in adults with type 1 and type 2 diabetes when used at mealtimes.

The FDA has issued a complete response letter to the company raising concerns about the use of in vitro performance data and clinical pharmacology data to bridge MannKind's next-generation inhaler to the phase III trials conducted using its earlier-generation MedTone inhaler.

The latest delay follows an initial complete response letter issued in early 2010. MannKind resubmitted the marketing application in July of last year, responding to the initial letter by providing clinical data from an efficacy study in patients with type 1 diabetes as well as updated pooled safety data. The FDA's target date to review the resubmission was set for late December, but at that time the agency said it would need four additional weeks to complete the review.

Having now completed the review of the resubmission, the agency said it still will require one new clinical trial using the next-generation inhaler in patients with type 1 diabetes and one in patients with type 2 diabetes. At least one of the trials should be a head-to-head comparison of the new device and the MedTone, the agency indicated.

The FDA has also asked for a range of other information that won't require new studies, including information on the performance characteristics, usage, handling, shipment and storage of the next-generation device and labeling changes.

The company noted that it had already begun trials similar to the research being requested by the FDA. "We plan 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," CEO Alfred Mann said in a statement.

"While we are disappointed with the complete response letter, we are encouraged that the FDA is asking for clinical studies only to confirm the bridging and handling of the next-generation device in order to compare it to the device used in our extensive clinical programme," he added.

20th January 2011

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