9.08.2005
WASHINGTON (AP) -- Federal health advisers on Thursday recommended government approval of the first inhaled form of insulin, offering some diabetics an alternative to many of their daily injections.
The recommendation by a Food and Drug Administration advisory panel came despite questions about use of the drug in people who have lung disease or were exposed to secondhand smoke.
Some advisers also were concerned that patients might not use the device properly. Drug company representatives suggested that the inhaler was not any more complicated than the injections many diabetics now must rely on.
Panel members twice voted 7-2 to recommend FDA approval of Exubera for each of the two most common types of diabetes. The drug is being produced by Pfizer, Sanofi-Aventis and Nektar Therapeutics.
The FDA usually follows the recommendations of its advisory committees, but is not required to.
The developers of the drug touted it as a way to persuade diabetics who are reluctant to take injections to get insulin.
The recommendation by a Food and Drug Administration advisory panel came despite questions about use of the drug in people who have lung disease or were exposed to secondhand smoke.
Some advisers also were concerned that patients might not use the device properly. Drug company representatives suggested that the inhaler was not any more complicated than the injections many diabetics now must rely on.
Panel members twice voted 7-2 to recommend FDA approval of Exubera for each of the two most common types of diabetes. The drug is being produced by Pfizer, Sanofi-Aventis and Nektar Therapeutics.
The FDA usually follows the recommendations of its advisory committees, but is not required to.
The developers of the drug touted it as a way to persuade diabetics who are reluctant to take injections to get insulin.
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