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Thursday, Sep 21, 2023

FDA Sets Afrezza Meeting Date

Mannkind Corp. announced on Friday that a Food and Drug Administration committee is scheduled on April 1 to review the application for its Afrezza brand of inhalable insulin. 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.

Joel Russel
Joel Russel
Joel Russell joined the Los Angeles Business Journal in 2006 as a reporter. He transferred to sister publication San Fernando Valley Business Journal in 2012 as managing editor. Since he assumed the position of editor in 2015, the Business Journal has been recognized four times as the best small-circulation tabloid business publication in the country by the Alliance of Area Business Publishers. Previously, he worked as senior editor at Hispanic Business magazine and editor of Business Mexico.

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