FDA Accepts AFREZZA Complete Response Resubmission And Sets Target Action Date

Main Category: Diabetes
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 Jul 2010 - 1:00 PDT

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MannKind Corporation (NASDAQ:MNKD) announced that it has submitted, and the U.S. Food and Drug Administration (FDA) has accepted, MannKind's resubmission of its New Drug Application (NDA) for AFREZZA™ (insulin human [rDNA origin]) and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act (PDUFA) action date of December 29, 2010.

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.

"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 Chief Executive Officer. "We will continue to work closely with the FDA during this final stage of the review process. We firmly believe AFREZZA has the potential to address a poorly-met need in diabetes therapy. Our primary goal is to make this novel therapeutic option available to patients as soon as possible."

About AFREZZA

AFREZZA™ (insulin human [rDNA origin]) is a novel, ultra rapid acting mealtime insulin therapy being developed by MannKind Corporation 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. 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, mimicking the release of meal-time insulin observed in healthy individuals. To date, the AFREZZA clinical program has involved more than 50 different studies and over 5,000 adult patients with both Type 1 and Type 2 diabetes.

Source:
MannKind Corporation

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