Washington – 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.
No specific restrictions were recommended for Exubera, but FDA officials said smokers probably would not be able to use the drug.
Their blood sugar could fall dangerously low with Exubera because they absorb much more inhaled insulin in their lungs than do nonsmokers.
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 advisers questioned the drug companies about the long-term effects of distributing insulin to the body through the lungs, rather than directly into the blood stream.
Rebecca Wilkes Killion, a patient representative member of the committee, said inhaled insulin could convince reluctant diabetics that they should take their medicine.
“I take four shots a day, and the fourth one is the hardest one,” Killion said. “I’m tired of it. If I could get myself down to one I’d be thrilled. A lot of people resist it because they are afraid of the needles.”
The companies, which are promoting Exubera as an easier-to-take alternative, proposed to conduct studies on the long-term effects of the drug until 2019.
During drug trials, researchers found that inhaled insulin generally was as effective as injections in controlling blood-sugar levels.
