09 September, 2005  21:27 GMT
 If it wins FDA approval, Exubera -- an inhaled form of insulin -- may allow some diabetics to get along with fewer injections.
Like other diabetics, Rebecca Wilkes Killion would be elated if she could reduce the number of times a day she has to inject herself with insulin to control her blood sugar.
She might be able to do just that, if the
Food and Drug Administration goes along with its advisers' recommendation that an inhaled form of insulin be approved for sale.
'Fourth One Is the Hardest'
"I take four shots a day and the fourth one is the hardest one," said Killion of Bowie, Md., who served as the patient representative on the panel during the hearing on the drug. "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."
Members of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 7-2 Thursday to recommend the agency approve the drug and inhaler device for each of the two major types of diabetes.
The FDA usually follows the recommendations of its advisory committees, but it isn't required to.
Not Enough Tests?
The insulin is being developed by
Pfizer,
Sanofi-Aventis and
Nektar Therapeutics, which are promoting it as a convenient alternative to the injections millions of diabetics must take several times a day.
Still, the inhaled insulin, called Exubera by its developers, presents some problems, as noted by the dissenters on the panel. In a separate vote, the panel voted 5-4 that the developers had not performed enough tests to determine the effects of inhaled insulin on people with lung disease.
Other panelists expressed concerns it would be difficult to train doctors and people with diabetes in the proper use and maintenance of the inhaler device.
Committee members recommended no specific restrictions on the drug, although it may be prohibited for use by smokers.
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