- The Washington Times - Friday, September 9, 2005


Federal health advisers yesterday 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 was made despite questions about use of the drug among 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 level 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 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 Inc., 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 bloodstream.

Rebecca Wilkes Killion, a patient representative member of the committee, said inhaled insulin could persuade reluctant diabetics to take their medicine.

“I take four shots a day, and the fourth one is the hardest one,” Mrs. 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.

“We understand the need to assess the long-term effects on pulmonary function,” said Dr. Neville Jackson of Pfizer.

During drug trials, researchers found that inhaled insulin generally was as effective as injections in controlling blood sugar levels. 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.

Inhaled insulin could be used to manage blood sugar levels for people with either type of diabetes who need insulin injections before meals.

The drug would not replace longer-acting insulin injections people with Type 1 diabetes need to take in the morning or before bed, according to FDA.

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