NEW YORK TIMES
January 28, 2006
U.S. Regulators Approve Insulin in Inhaled Form
By ANDREW POLLACK and ALEX BERENSON
An inhaled form of insulin won federal approval yesterday, offering the first alternative to injections for millions of people with diabetes since the drug was introduced in the 1920's.
The new inhaler could offer more convenience and less pain for many of the roughly five million Americans already using insulin, diabetes experts say.
Analysts predict that the therapy, called Exubera and sold by Pfizer, will be popular, with worldwide sales of as much as $2 billion a year by 2010. Pfizer said it planned to begin selling Exubera this summer.
But some doctors say they are concerned that Exubera's risks to the lungs have not been properly tested, especially because Exubera works no better than injected insulin at controlling blood sugar. In clinical trials, Exubera caused a slight reduction in patients' ability to breathe.
[Keine Droge ohne Nebenwirkungen. Mit Pech kommen Sammelklagen wegen "Exubera-Erstickung" - A. L.]
The Food and Drug Administration is recommending that patients have their lung function checked before starting Exubera and every 6 to 12 months afterward.
Assuming Exubera proves safe for long-term use...
[sollte so etwas bei einer FDA-Zulassung nicht schon geklärt sein?! - A. L.]
, the therapy could have a big impact on public health by overcoming the reluctance of some Type 2 diabetics to use insulin. Insulin is the most reliable method of controlling blood sugar, the key to reducing the risk of complications of diabetes, which affects about 20 million Americans.
"The thing that people with diabetes who have to take insulin hate the most are shots," said Dr. Robert Goldstein, chief scientist of the Juvenile Diabetes Research Foundation International. "So anything that can replace shots patients are going to be very pleased to have."
Exubera uses a powdered form of insulin and a special inhalation device initially developed by Nektar Therapeutics, a biotechnology company in San Carlos, Calif. The inhaler is about the size of an eyeglass case when not in use and about a foot long when it is used. It combines pressurized air with the insulin powder to create a powdered cloud of insulin that diabetics breathe in over several seconds.
David Kliff, who takes insulin for his Type 2 diabetes and publishes the Diabetic Investor newsletter about diabetes-related companies, said the inhalation device might be too big and cumbersome to attract users.
"I can't see somebody whipping this out in public and using it," Mr. Kliff said. "People with diabetes are sensitive enough as it is."
But Paul Matelis of Miami, who has used the device in clinical trials for seven years, disagreed. "I've used it at the Orange Bowl," he said.
[Vielleicht kann man damit auch öffentlich "Crack" naschen ;-)) - A. L.]
Mr. Matelis, 54, who has Type 1 diabetes, said the inhaler was much more convenient than syringes. "It's much easier to take a puff than to load up a syringe and inject yourself in a moving vehicle," he said.
Nektar licensed the insulin and the device to Pfizer, the world's largest drug company, which will pay Nektar a royalty of 15 percent on sales. Pfizer has not announced a price for Exubera, though analysts project it will cost two or three times as much as injected insulin.
About 90 percent of Americans with diabetes have Type 2, which has been linked to obesity and inactivity. In Type 2 diabetes, the body does not effectively use its insulin, a hormone that is needed to process blood sugar, and can slowly lose the ability to produce it. Most people with Type 2 do not take insulin, although some experts say more patients should because they do not control their blood sugar adequately.
In Type 1 diabetes, which often begins in childhood, the body is unable to produce insulin, and so people depend on injections.
Exubera was approved for adults with either type of diabetes. It is designed to be taken at mealtime, meaning that people with Type 1 and some with Type 2 will still have to take one or two injections a day of longer-acting insulin. They will also still have to prick their fingers to measure their blood sugar levels.
[Es bleibt also bei zwei Spritzen pro Tag! Das ist nicht so toll... - A.L.]
The F.D.A.'s approval yesterday marks the end of a long medical quest, said Dr. Michael Berelowitz, a senior vice president of Pfizer. Scientists have tried to find ways to make insulin inhalable almost since they began to produce it, he said.
"It is not natural to have to inject insulin, and many people find it difficult," Dr. Berelowitz said.
It took Nektar years to develop insulin with particles of a size that could make it into the lungs and be stable without refrigeration. Insulin is a protein, and it cannot be taken orally because it would be destroyed by acids in the stomach.
Pfizer, in consultation with the F.D.A., delayed seeking approval for Exubera for at least two years while conducting more research because of concerns that it might damage the lungs. Since 2004, lawmakers and consumer groups have sharply criticized the F.D.A. for approving potentially unsafe drugs like Vioxx.
But an advisory panel to the agency recommended approval of the product in September, at least for patients without pre-existing lung diseases. The agency itself, after putting off a decision for three months, concurred.
"I think that we and the advisory committees felt that there was very robust data with regard to the safety of the drug in patients without underlying lung disease," said Dr. Robert Meyer, director of the F.D.A. office overseeing diabetes drugs.
But some experts say the risks of using the product day after day for life have not been ascertained. "We don't have long-term studies on this medication," said Dr. Marc Sandberg, the medical director of the Diabetes Health Center in Flemington, N.J.
Because of the safety questions, Exubera was not tested much in children and is not approved for them. It is also not recommended for people with asthma, bronchitis or emphysema. Also, smokers or those who have quit smoking within six months are not supposed to use the product because their lungs absorb too much of it, posing the risk of an overdose.
Pfizer has committed to conduct additional safety studies and will monitor whether problems arise as Exubera goes into widespread use.
Other companies are now racing to develop their own inhaled insulins, including big manufacturers like Eli Lilly and Novo Nordisk and smaller ones like MannKind and Kos Pharmaceuticals.
[Wie ich schon sagte: Die Konkurrenz schläft nicht... A.L.]
But Pfizer is considered two years or more ahead of the competitors. One reason could be that big insulin producers initially were not interested in Nektar's invention, thinking there would not be a big market for it, said John Patton, co-founder and chief scientist of Nektar. But Pfizer was not in the insulin business and saw a new opportunity, he said.
To obtain insulin, Pfizer made a deal with Aventis, now known as Sanofi-Aventis. Pfizer recently agreed to pay $1.3 billion to buy out its partner.
Analysts predict that Exubera will rapidly become a blockbuster drug, a term used in the industry to describe a treatment with more than $1 billion in annual sales. Ian Sanderson, an industry analyst at SG Cowen, predicted that Exubera, which was also approved in Europe this week, will have $1.8 billion in annual sales worldwide by 2010, including $1.1 billion in the United States.
"I've been astounded at the patient response to Exubera," Mr. Sanderson said.
Mr. Sanderson predicted that Exubera would cost between $120 and $150 a month, roughly comparable to the price of pills taken by some people with Type 2 diabetes but about three times the price of injectable insulin.
Dr. Jay Skyler, associate director of the diabetes research center at the University of Miami, said thinner needles and penlike injectors have taken much of the sting out of shots.
He said the benefit of inhaled insulin would be mainly for "people who have never been on an injection, that are really desirous of going onto this instead of injections because they think the injections are going to be difficult for them."
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