FDA approves first inhalable version of insulin

updated 8:49 p.m. ET Jan. 27, 2006

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. It should be available to patients by midyear, Pfizer said.

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.

Needles still needed
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.

MORE FROM DIABETES

Diabetes Section Front

Study: Coffee, tea may lower diabetes risk Obesity rates highest in Southeast, Appalachia Tiny tattoos could help diabetics ditch needles Diabetes can be delayed with diet, exercise Diabetes drug helps obese adults loss weight Long-acting insulin boosts diabetes care Chinese herbs may help prevent diabetes Sidewalks and parks can cut diabetes risk Walking may help control diabetes Treating mild diabetes during pregnancy helps Diabetes Section Front   Add Diabetes headlines to your news reader: