Diabetics in the US and Europe are getting their first alternative to the regular needle jabs of insulin they've endured since the discovery in the 1920s of the hormone that controls blood sugar levels.
Pfizer Inc hopes to begin selling Exubera, the first inhalable version of insulin to win US federal approval, by midyear.
Use of rapid-acting inhaled insulin will not replace the need to inject the hormone occasionally, according to the US Food and Drug Administration (FDA). Diabetics also will have to continue pricking their fingers to test blood sugar levels.
The FDA approved Exubera on Friday, one day after the European Commission.
Exubera will provide an option for those adults with Types 1 or 2 diabetes reluctant to use the syringes, pens and pumps currently needed to inject insulin, Pfizer said. In clinical trials, Exubera managed blood sugar levels just as well as injected insulin.
Pfizer jointly developed the drug and dispenser with Sanofi-Aventis and Nektar Therapeutics. Analysts said it could become a US$1 billion-a-year seller.
The American Diabetes Association estimates nearly 21 million people in the US have diabetes and that about 5 million of them need daily insulin injections. About 15 percent of diagnosed diabetics do not take the insulin or pills they should, the association estimates.
In Europe, there are an estimated 48 million diabetics.
The Exubera device is about the size of an eyeglass case.
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