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MannKind receives complete response letter for inhaled insulin therapy
Monday, March 15 2010 | Comments
What's This?
The Food and Drug Administration sent a complete response letter to MannKind Corp. regarding the approval application for its inhaled insulin treatment.The company submitted a New Drug Application (NDA) last March to market Afrezza (insulin monomer human [rDNA origin]) inhalation powder and the Afrezza inhaler as a treatment to control hyperglycemia in adults with type 1 or type 2 diabetes.
However, MannKind said the FDA is now requesting information and currently available clinical trial data that support the clinical utility of Afrezza, as well as information about the comparability of "the commercial version" of the product's inhaler device relative to the version used in clinical trials.
MannKind said it was not planning to launch the drug with the commercial version of the inhaler device. Instead, the firm had intended to "follow the original NDA" for the product and then submit a supplemental NDA to market a next-generation version of the 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," said Alfred Mann, the company's chief executive officer. "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."
The FDA did not ask MannKind to conduct additional trials of Afrezza, nor did it cite any safety concerns, but it did ask for updated safety data. In addition, the agency requested changes to the proposed labeling of the product's cartridges, foil pouches and cartons.
The company said it would respond to the FDA's requests in a timely manner.
MannKind shares closed at $7.89, down $2.59, or 24.7 percent, in heavy volume on the Nasdaq.
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