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.
“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 Exubera device is about the size of an eyeglass case. It delivers insulin as a dry powder packaged in 1- or 3-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.
Diabetics with either type 1 or 2 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.
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.
Talk to us
> Give us your news tips.
> Send us a letter to the editor.
> More Herald contact information.