WASHINGTON – Federal health advisers on Thursday recommended government approval of the first inhaled form of insulin (search), 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.
Exubera 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.
According to briefing documents released Wednesday by the Food and Drug Administration, concerns about the inhaled insulin (search) centered on its long-term effects on the lungs, and whether it is effective and safe for smokers, children and patients with lung disease.
More than 18 million people in the United States are estimated to have diabetes (search), although 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.
Inhaled insulin could be used to manage blood sugar levels (search) for people with either type who need insulin injections before meals. It wouldn't replace longer-acting insulin injections people with Type 1 diabetes need to take in the morning or before bed, according to FDA briefing documents.
During drug trials, researchers found that inhaled insulin was generally as effective as injections in controlling blood sugar levels. However, some patients who took inhaled insulin complained of coughing and a small decrease in breathing capacity.
On Friday, the advisory committee will consider another Type 2 diabetes (search) treatment, muraglitazar, developed by Bristol-Myers Squibb. Tablets would be sold under the trade Pargluva and would control blood sugar levels.