Inhaled diabetes drug wins approval

WASHINGTON— Federal health advisers yesterday recommended U. S. 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 came despite questions about use of the drug in people who have lung disease or were exposed to second- hand smoke. The drug, Exubera, will not be for use by smokers, the U. S. government said. 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 now must rely on.

Panel members twice voted 7- 2 to recommend FDA approval of Exubera for each of the two most common types of diabetes. Pfizer, Sanofi-Aventis and Nektar Therapeutics are producing the drug. The FDA usually follows the recommendations of its advisory committees, but is not required to.

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 U. S. have diabetes, although some do not know it. More than 2 million people in Canada have the chronic disease.

Health Canada said yesterday it has no idea when Exubera might be available for sale in Canada. “ Health Canada has not a received a submission for the approval of Exubera for sale in Canada,” said Nathalie Lalonde, a department spokesoman.

Lalonde said the manufacturer would need to submit an application to Health Canada before Exubera could be sold here. Depending on the specifics of the application, she said, the turnaround time before the drug could be approved is less than a year.