WASHINGTON, March 28 (Reuters) - An initial review of MannKind Corp’s experimental inhaled insulin device, Afrezza, by U.S. Food and Drug Administration staff raised multiple questions about its safety and effectiveness in treating diabetes.
The reviewers issued their report before a meeting on April 1 of outside advisers to the FDA who will discuss clinical trial data and advise on whether the product should be approved.
Afrezza is a whistle-sized inhaler designed to deliver more effective, rapid-acting insulin than injectable products offered by Eli Lilly and Co. and Denmark’s Novo Nordisk .
The FDA staff review raised questions about dosing, missing data, bronchospasms, and Afrezza’s affect on lung function. (Reporting by Toni Clarke in Washington; Editing by Doina Chiacu)