Inhaled insulin approved

Published January 29, 2006

WASHINGTON, Jan 28: The first inhaled version of insulin won US approval on Friday, offering an alternative for some of the daily shots millions of diabetics use to control blood sugar and prevent complications from the disease.

The Pfizer Inc product, Exubera, was approved for adults with either Type 1 or Type 2 diabetes. Industry analysts forecast sales will top $1 billion a year.

More than five million Americans use insulin daily to help manage blood sugar levels and prevent complications such as heart disease, blindness and limb amputations.

Exubera is not a substitute for all of the insulin shots many of them need. The new product is a short-acting powder form of insulin that can be taken before meals.

Many patients, including nearly all Type 1 diabetics, still will need to get long-acting insulin by injection, Food and Drug Administration officials said.

Exubera ‘will not replace all injectable insulin and should not be used by smokers’, stressed Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research.

Smokers should avoid Exubera because more of the inhaled insulin gets in their blood, putting them at risk for an overdose.

FDA officials also advised against use by patients with asthma or other chronic lung conditions until more research determines if inhaled insulin is safe for them.

The Exubera inhaler, invented by Nektar Therapeutics Inc., weighs about 110 grams and is about the size of an eyeglass case when closed, Pfizer said.

Side effects include coughing, shortness of breath, sore throat and dry mouth.—Reuters

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