An initial review of MannKind Corp's experimental inhaled insulin device by U.S. Food and Drug Administration staff raised questions about its safety and effectiveness but was less damning than some investors had expected, sending the company's stock up more than 10 percent in pre-market trading. The reviewers issued their report before an April 1 meeting of outside advisers to the FDA who will discuss clinical trial data and advise on whether the product, Afrezza, 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 effect on lung function.
via Health News Headlines - Yahoo News http://ift.tt/1jCJouR
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