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Setback for MannKind's inhaled insulin

The US Food and Drug Administration has cancelled its end-of-review meeting with MannKind Corporation regarding the company's Afrezza inhaled insulin

The US Food and Drug Administration (FDA) has cancelled its end-of-review meeting with MannKind Corporation regarding the company's Afrezza inhaled insulin, adding another factor to what has already been a difficult regulatory review for the product.

End-of-review meetings are scheduled at the drug sponsor's request if a marketing application is denied. The meetings are intended to provide feedback from the FDA about improving the submission.

MannKind has been issued two complete response letters from the FDA declining to approve the Afrezza new drug application. The first, issued in early 2010, asked for clinical data from an efficacy study in patients with type 1 diabetes as well as updated pooled safety data.

The second letter, issued in January of this year, requested two additional clinical trials due to 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.

MannKind had hoped to meet with the FDA to ensure that clinical trials it is currently conducting will suffice in addressing the agency's questions. However, the FDA said several days ago that it was cancelling the end-of-review meeting that had been scheduled for April 15 due to the government shutdown that appeared to be looming at the time.

"While the FDA cancelled the meeting with MannKind, we note that other FDA meetings planned for this week will go on as scheduled," Hapoalim Securities analyst Jon LeCroy wrote in a research note. "As when the FDA failed to give MannKind the official minutes from its meeting after the 2010 Afrezza complete response letter, it appears to us that the FDA is sending a signal that it has no interest in the Afrezza programme."

The FDA did not offer MannKind a new date for the meeting, but said it will reschedule "when it is able to do so," according to MannKind. The company said it expects to be able to provide more details during its first-quarter analyst call on April 25.

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.

In February 2011, MannKind announced it is to cut about 41 per cent of its workforce after the second complete response letter from the FDA declining approval for Afrezza put the company into "full contingency plan mode" according to CEO Hakan Edstrom.

13th April 2011

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