FDA approves first inhaled version of insulin for diabetics

WASHINGTON -- The first inhalable version of insulin won federal approval Friday, giving millions of adult diabetics an alternative to some of the injections they now endure.

The Food and Drug Administration said the Pfizer Inc. insulin, to be marketed as "Exubera," is the first new way of delivering insulin since the discovery of the hormone in the 1920s. Pfizer jointly developed the drug and dispenser with Sanofi-Aventis and Nektar Therapeutics.

Use of rapid-acting inhaled insulin will not replace the need to inject the hormone occasionally, according to the FDA. And diabetics will have to continue pricking their fingers to test blood sugar levels.

The American Diabetes Association estimated that nearly 21 million people in the United States have diabetes. About 5 million need insulin injections.

Analysts said the inhaled insulin could eventually become a $1 billion-a-year seller for Pfizer, which recently agreed to pay Sanofi-Aventis $1.3 billion to obtain full worldwide rights to the drug for use by both Type 1 and 2 adult diabetics.

"It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research.

The European Commission approved Exubera for use in adults on Thursday.

In clinical trials, Exubera managed blood sugar levels just as well as injected insulin, but an independent FDA panel in September stressed that use of inhaled insulin will not mean diabetics can toss out the needles, pens or pumps used to inject the hormone.

Inhalable insulin is a welcome advance, said Dr. Nathaniel Clark, the national vice president for clinical affairs for the American Diabetes Association. But he added that needles still will allow a patient to better control dosage.

Dr. Robert Meyer, who oversees the FDA's Division of Metabolic and Endocrine Drugs, said, "We feel like this has been established as a reliable dosage form."

The FDA review panel expressed concern about the bulkiness of the dispenser and about some patients who experienced coughing or a slight decrease in lung capacity when using the drug. Pfizer will study the long-term effects of Exubera on the lungs, as well as its safety and effectiveness in patients with lung disease.

Diabetics with either type of the disease could use the rapid-acting inhaled insulin before or after meals to manage their blood sugar levels. However, the drug would not replace the longer-acting insulin injections that some diabetics, particularly those with Type 1 diabetes, need to take in the morning or before bed.

Elise Rayner, of Colorado Springs, Colo., said she declined to participate in a clinical trial of inhaled insulin.

"My reaction was, I have excellent control of my blood sugars right now and I just don't have any interest in messing with a good thing," said Rayner, 33, who's used both insulin injections and the pump for her Type 1 diabetes.

Most diabetics have Type 2, a condition linked to obesity that occurs when the body cannot effectively use the insulin it makes. In some cases, the disease can be managed with pills when matched with a diet, exercise and weight-management plan.

Pfizer believes Exubera will encourage diabetics who are squeamish about needles to take the insulin. About 15 percent of diagnosed diabetics do not take the insulin or pills they should, the American Diabetes Association estimates.

Better control of blood sugar levels allows diabetics to ward off serious complications, including diseases of the eye, kidneys and nerves. The latter can lead to ulcers and infections in the legs and feet and, in some cases, amputations.

The Exubera device is about the size of an eyeglass case. It delivers insulin, as a dry powder packaged in one- or three-milligram inhalable capsules, to the lungs through the mouth, according to Pfizer.

Diabetics with asthma, poorly controlled or unstable lung disease, or who smoke or recently quit, shouldn't use Exubera, the FDA said. And patients should have their lungs checked before using the drug, as well as at six- to 12-month intervals after that.

"It's not going to be an overnight sensation," said Dr. Robert Goldstein, chief scientific officer for the Juvenile Diabetes Research Foundation International. "My concern is that people will assume they are now free of insulin shots."

Deutsche bank analyst Barbara Ryan said she expects a daily supply of Exubera will cost about $4 to $5. Treatment with injected insulin costs $1 to $1.50, she said.