Inhaled Insulin Passes Key Step
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.
Exubera, could help diabetics who are reluctant to take injections. The insulin is being developed by Pfizer Inc., Sanofi-Aventis and Nektar Therapeutics.
During drug trials, researchers found that inhaled insulin was generally as effective as injections in controlling blood sugar levels.
"Inhaled insulin would be more acceptable for some patients," Eugene Barrett, MD, PhD, immediate past president of the American Diabetes Association, and director of the Diabetes Center at the University of Virginia Health System, told WebMD earlier this year.
Patients who won't take insulin shots — even when their doctors tell them to do so — would take the inhaled form of the hormone, said Nick Freemantle, PhD, of the University of Birmingham, U.K., who conducted research for Pfizer and Aventis.
However, some patients who took inhaled insulin complained of coughing and a small decrease in breathing capacity.
It is estimated that more than 18 million people in the United States have diabetes, 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 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 documents.
On Friday, the advisory committee will consider another Type 2 diabetes treatment, muraglitazar, developed by Bristol-Myers Squibb. Tablets would be sold under the trade Pargluva and would control blood sugar levels.