FDA approves first inhaled version of insulin for diabetics
1/27/2006WASHINGTON The first inhalable version of insulin won federal approval TOday, giving millions of adult diabetics an alternative to some of the regular 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.
Use of rapid-acting inhaled insulin will not replace the need to occasionally inject the hormone, according to the FDA. And diabetics would have to continue pricking their fingers to test blood sugar levels.
The FDA delayed its decision by three months so it could review chemistry data on the diabetes treatment. The European Commission approved Exubera for use in adults on Thursday.
Analysts have 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.
Until today, patients with diabetes who need insulin to manage their disease had only one way to treat their condition, said Dr. Steven Galson, director of the FDA s Center for Drug Evaluation and Research. It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars.
The world s largest pharmaceutical company initially will have the inhaled insulin market to itself.
We will be the first out there and for a while, said John LaMattina, president of global research and development for Pfizer. Eli Lilly and Co., Kos Pharmaceuticals Inc., MannKind Corp. and Novo Nordisk A/S all are developing their own versions.
Clinical trials found that 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.
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