WASHINGTON, March 28 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
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