FDA Panel to Consider Afrezza in AprilFriday, January 10, 2014
Mannkind Corp. announced on Friday that a Food and Drug Administration advisory committee is scheduled on April 1 to review an updated application for its Afrezza inhalable insulin product.
The Valencia biotech originally tried to get permission to market Afrezza in 2009, but the FDA demanded more data to reach a decision. The agency later asked for more Phase 3 clinical studies, which the company has performed. It submitted its latest application in October for FDA review.
The company said the target date for the FDA to complete its review and issue a decision on Afrezza is April 15.
MannKind has no products on the market, and Afrezza is its lead pipeline drug. The company was founded by billionaire entrepreneur Alfred Mann.
Shares closed down $1.16, or 16 percent, to $5.92 in trading on the Nasdaq. On Thursday, shares had risen 18 percent to $7.08 apparently after word of some kind of announcement surfaced.