MannKind Wins U.S. Panel Backing for Its Inhaled Insulin
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MannKind Corp.’s inhaled diabetes treatment won the backing of a U.S. advisory panel, moving the company another step closer in its long-running effort get its first product on the market. The shares rose 74 percent.
Food and Drug Administration advisers voted 13-1 and 14-0 yesterday that the drug, Afrezza, should be approved for Type 1 and Type 2 diabetes, respectively. The FDA doesn’t have to follow the recommendation. FDA staff raised concerns in a report March 28 that the medicine may affect lung function and questioned missing data from a study of Type 1 patients.