FDA considers inhaled insulin

WASHINGTON (AP) -- A government advisory panel is set to consider the first insulin that can be inhaled rather than injected, a novel approach to keeping diabetics' blood sugar under control without needles.
The insulin, called Exubera by its manufacturer, is pitched as a significant improvement in the quality of life for diabetics, one that could persuade some who refuse to take injections to use insulin more regularly. The insulin is being developed by Pfizer, Sanofi-Aventis and Nektar Therapeutics.
According to briefing documents released Wednesday by the Food and Drug Administration, concerns about the inhaled insulin center on its long-term effects on the lungs, and whether it is effective and safe for smokers, children and patients with lung disease.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet today in suburban Washington to consider whether to recommend the drug to government regulators for approval. The FDA usually follows the recommendations of its advisory committees, but it isn't required to.
More than 18 million people in the United States are estimated to have diabetes, though some do not know it. Most have Type 2, a condition linked to obesity that occurs when the body cannot effectively use the insulin it makes. Sometimes this can be treated with pills instead of injections.
Fewer than 10 percent have Type 1, a disorder in which the immune system attacks insulin-producing cells in the pancreas. This is sometimes called juvenile diabetes.
The number of people in the United States who have diabetes is believed to have tripled in the last quarter-century.
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