The FDA still has the final word on whether to endorse the inhalers that could replace daily shots for some diabetics.
By Associated Press
Published September 9, 2005
WASHINGTON - 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.
"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 on 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 do so. 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. They say many diabetics who have trouble taking all their injections will be much more likely to use an inhaler.
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. Drug company representatives suggested the inhaler was not any more complicated than the injections many diabetics now must rely on.
Committee members recommended no specific restrictions on the drug, although Dr. David Orloff, director of the FDA division that would oversee the drug, said it would probably be prohibited for use by smokers, whose blood sugar could drop dangerously low because their lungs would absorb much more inhaled insulin.
Panelists also said they were concerned the drug had not been adequately tested on people who do not smoke but are regularly exposed to secondhand smoke.
Orloff said the FDA would take all the panel's concerns into account.
The companies 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 more than 18-million people in the U.S. have diabetes, although some do not know it. The number of people with diabetes is believed to have tripled in the past quarter-century.
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.
An FDA medical officer questioned whether inhaled insulin could provide a precise enough dose to treat people with Type 1 diabetes.
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 some diabetics, particularly those with Type 1 diabetes, need to take in the morning or before bed, according to FDA documents.
HOW IT WORKS
The inhaled insulin comes in a dry-powder delivery system similar to some asthma inhalers. When it hits the lungs, it's absorbed directly into the bloodstream, making it take effect faster than injected insulin.