Inhaled Insulin Wins U.S. Approval

Federal regulators Friday approved the first inhaled insulin treatment, offering millions of diabetics a chance to ease the grueling ritual of repeated daily injections.

Called Exubera, the drug allows patients to control their blood-sugar levels by inhaling a fine insulin powder through a flashlight-size device. The drug, to be marketed by Pfizer Inc., could reduce or eliminate the need for before-meal insulin shots.

Despite the inhaler’s large size and some concerns about the safety of the drug, which causes a slight decrease in patients’ breathing capacity, Exubera could change the way diabetes is treated.

“Being able to inhale something, if it works, would make life so much easier,” said 45-year-old Laurie Dreyer Hadley of Roseville, Calif., who wasn’t bothered by the inhaler’s size. “I have the world’s biggest purse to carry my insulin supplies.”

The Food and Drug Administration approved Exubera only for adults with diabetes. Pfizer plans to conduct a three-year study on children.

The company said Exubera won’t be available until midyear, giving it time to start up production and launch education programs for doctors and patients.

Analysts say Exubera marks the beginning of what could be a new class of drug. Two rivals to Pfizer are working on inhaled insulin that would be delivered in smaller devices, and other companies are developing an inhaled version of an injectable drug for osteoporosis.

More than 20 million Americans have diabetes and about one-quarter inject insulin daily because their bodies do not produce enough insulin or use insulin effectively. If diabetics do not manage their blood sugar, serious complications -- including heart disease, kidney failure and blindness -- can develop.

Many diabetics, however, are reluctant to start insulin because they loathe taking injections.

“They perceive it is going to be painful,” said Jay Skylar of the Diabetes Research Institute in Miami. “If [Exubera] facilitates patients moving from oral drugs to insulin, it should result in better overall glucose control nationwide. That’s a really good thing.”

Skylar predicted that Exubera -- which will be available later this year at a price that has yet to be announced -- would be popular. “The idea of not having to inject insulin resonates with people,” he said.

Insurance companies have not yet said if they will cover the drug, but are likely to do so because uncontrolled diabetes can lead to far more costly health problems, said Zach Wagner, an analyst with Edward Jones.

“We’re saying it will be a blockbuster,” with eventual sales of $1 billion a year, he said.

The incidence of diabetes has grown by more than 60% in the last 15 years, an increase most researchers attribute to a corresponding rise in obesity.

Pfizer said its own research indicated that the majority of diabetics would prefer Exubera over injections. “The number of people who would give up needles is overwhelming,” said David A. Simmons, director of Pfizer’s Exubera medical team.

The FDA cautioned that the inhaled drug was not a substitute for all kinds of insulin shots. Exubera is an alternative to short-acting shots taken before meals, but will not replace long-acting shots that some diabetics take at bedtime in addition to mealtime injections.

Most people with Type 1 diabetes, which usually strikes in childhood, and some people with Type 2, or adult-onset diabetes, use long-acting insulin. About 95% of diabetes patients have Type 2.

“We want to make sure people understand that this does not equal getting rid of all their insulin shots,” said Robert Goldstein, chief scientific officer of the Juvenile Diabetes Research Foundation.

The drug’s label will warn that smokers should not use Exubera because smoking increases the effects of inhaled insulin and could cause dangerous drops in blood-sugar levels. Patients with lung conditions such as asthma or chronic obstructive pulmonary disease also should not use it unless future research shows the drug is safe for them.

Side effects are relatively minor and include coughing, sore throat and dry mouth.

In approving the drug Friday, the FDA said Pfizer agreed to conduct more safety studies of Exubera after it reaches the market. The company will track 5,000 patients over five years to determine if lung function decreases over time. Pfizer also must study the drug in patients with underlying lung disease.

Unresolved safety issues concerned Beth Doty of Tacoma, Wash., who said she otherwise would love to use Exubera. “I’ve always had a problem with needles, and have not been able to control my [blood] sugar the way I would like to because of that. It would help me be a healthier person.”

Pfizer said it invested more than $1 billion in Exubera, and overcame numerous technical and regulatory challenges to win approval of the product. Three years ago, the FDA delayed its review of the drug so Pfizer could conduct more safety studies.

After word of the FDA approval leaked out early in the day, Pfizer stock gained nearly 4% to close at $25.99.

The approval also was welcomed by Nektar Therapeutics, a small San Carlos, Calif., company that invented the drug and licensed it to Pfizer. Its shares rose 13 cents to close at $20.75, and gained an additional 45 cents in after-hours trading following the FDA announcement.

John S. Patton, Nektar Therapeutics’ founder and chief scientist, said it took the company 15 years to develop an inhaled form of insulin that would be properly absorbed by the lungs, and a device that could deliver the drug in consistent amounts.

“This is huge,” Patton said by telephone from the company’s headquarters. “I’m spraying everyone with champagne.”

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Diabetes numbers

20.8 million people in the U.S. have diabetes (7% of the population).

14.6 million people have been diagnosed.

6.2 million people have the disease but don’t know it.

1.5 million new cases of diabetes were diagnosed in people ages 20 and older in 2005.

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Treatment with insulin or oral medication among adults with diagnosed diabetes

Oral medication only: 57%

Insulin only: 16%

Insulin and oral medication: 12%

Neither: 15%

Numbers are estimates.

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Sources: National Diabetes Information Clearinghouse