FDA OKs inhaled version of insulin


Published: Saturday, January 28, 2006 at 6:01 a.m.
Last Modified: Friday, January 27, 2006 at 10:34 p.m.
WASHINGTON - The first inhalable version of insulin won federal approval Friday, 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 will have to continue pricking their fingers to test blood sugar levels.
The American Diabetes Association estimated that nearly 21 million people in the U.S. have diabetes, although about one-third do not know it. The number of people with diabetes is believed to have tripled in the past quarter-century. About 5 million Americans now inject insulin daily.
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 by 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."
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.
Inhalable insulin is a welcome advance, said Dr. Nathaniel Clark, the national vice president for clinical affairs for the American Diabetes Association. But he added that needles still will allow a patient to better control dosage.
"Injecting insulin is far more precise in the sense of, what you want to deliver you deliver. You don't have to deal with any questions of how much is delivered through the lungs," Clark said.
Dr. Robert Meyer, who oversees the FDA's Division of Metabolic and Endocrine Drugs, said: "We feel like this has been established as a reliable dosage form."
The FDA review panel also expressed concern about the bulkiness of the Exubera dispenser and about some patients who experienced coughing or a slight decrease in lung capacity when using the drug. Pfizer will conduct studies on the long-term effects of Exubera on the lungs, as well as the safety and effectiveness of the drug on patients with lung disease, the FDA said.
Diabetics with either type of the disease 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.
"You're not going to eliminate the needles in Type 1. For Type 2, it really depends on the stage," said Dr. Will Cefalu, a clinical investigator for both Pfizer and Eli Lilly and Co., which is developing its inhalable insulin system with Alkermes Inc.
Most diabetics have Type 2, a condition linked to obesity that occurs when the body cannot effectively use the insulin it makes. Sometimes the disease can be treated with pills instead of injections when matched with a diet, exercise and weight-management plan.
Pfizer believes Exubera will encourage diabetics who are squeamish about needles to take the insulin they need to tightly control their blood sugar levels. About 15 percent of diagnosed diabetics do not take the insulin or pills they should, according to American Diabetes Association estimates. Better control of blood sugar levels allows diabetics to ward off other serious complications, including diseases of the eye, kidneys and nerves. The latter can lead to ulcers and infections in the legs and feet and, in some cases, amputations.
The Exubera device is about the size of an eyeglass case. It delivers insulin, as a dry powder packaged in one- or three-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.
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.
"It's not going to be an overnight sensation," said Dr. Robert Goldstein, chief scientific officer for the Juvenile Diabetes Research Foundation International. "My concern is that people will assume they are now free of insulin shots."

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