MannKind announces Advisory Committee approval for inhaled insulin product

The product, AFREZZA, has a PDUFA review date of July 15, 2014

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VALENCIA, Calif.—Biopharmaceutical company MannKind Corporation, which focuses on the discovery, development and commercialization of therapeutic products for diseases such as diabetes, has announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 1 to recommend that MannKind’s AFREZZA (insulin human [rDNA origin]) Inhalation Powder be granted FDA marketing approval for improving glycemic control in adults with type 1 diabetes, and voted 14 to 0 that it be granted marketing approval for the improvement of glycemic control in adults with type 2 diabetes.
“We are pleased with the Advisory Committee’s approval recommendation in support of AFREZZA, and we appreciate the thoroughness of their review,” Alfred Mann, chairman and CEO of MannKind Corporation, said in a press release. “We look forward to working with the FDA as they complete their evaluation of AFREZZA. Diabetes is a major health problem in the United States, and we are committed to bring AFREZZA to the many patients who might benefit from this novel product.”
AFREZZA is a novel, ultra rapid-acting mealtime insulin therapy, a drug-device combination product that consists of AFREZZA Inhalation Powder delivered via a small inhaler. The powder is administered at the beginning of a meal, whereupon it dissolves immediately after inhalation to the deep lung and then delivers insulin to the bloodstream. With this product, peak insulin levels are achieved within 12 to 15 minutes after administration, a far more rapid effect than the traditional times of 45 to 90 minutes for injected rapid-acting insulin analogs and 90 to 150 minutes for injected regular human insulin. Should it gain FDA approval, it will stand as the first ultra rapid-acting mealtime insulin therapy available for diabetes patients in the United States.
The first successful clinical research trial using an artificial pancreas in conjunction with AFREZZA was announced in September 2013 by JDRF, Sansum Diabetes Research Institute and the College of Engineering at the University of California, Santa Barbara. The organizations noted in the release that the trial “establishes that the disease can be managed through a unified automated process that delivers precise amounts of insulin around the clock, based on real-time glucose measurements without the need for patient intervention, and is further enhanced and fine-tuned by the swift delivery of ultra-rapid-acting inhaled insulin during mealtimes. The artificial pancreas and inhaled insulin system work together to replicate the normal, healthy function of the human pancreas. This combination therapy has the ability to greatly improve the regulation of prandial and postprandial blood glucose levels.” JDRF provided funding for the research.
While the FDA is not bound by the Advisory Committee’s recommendation, it will take the vote into consideration while reviewing MannKind’s New Drug Application for AFREZZA. The original Prescription Drug User Fee Act date for the FDA to review AFREZZA was April 15, though that has been extended to July 15 to give the FDA enough time to review all the submitted information.

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