FDA Approves Inhalable Version of Insulin
WASHINGTON - Diabetics are getting an 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 federal approval, by midyear.
Use of rapid-acting inhaled insulin will not replace the need to inject the hormone occasionally, the Food and Drug Administration said. It approved Exubera on Friday, a day after the multinational European Commission did so.
Diabetics also will have to continue pricking their fingers to test blood sugar levels.
Exubera will provide an option for adults with Type 1 or 2 diabetes who are 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 $1 billion-a-year seller.
The American Diabetes Association estimates that nearly 21 million people in the United States have diabetes and 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 group says.
FDA and Pfizer doctors believe Exubera may encourage diabetics to make more frequent and better use of insulin.
"It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research.
Improved control would allow diabetics to ward off serious complications, including diseases of the eye, kidneys and nerves.
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 allow better dosage control.
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."
An FDA review expressed concern about some patients who experienced coughing or a slight decrease in lung capacity when using the drug. Pfizer will study the long-term effects of Exubera on the lungs, as well as its safety and effectiveness in patients with lung disease.
Diabetics with asthma, poorly controlled or unstable lung disease, or a smoking habit shouldn't use Exubera, the FDA said. Patients should have their lungs checked before using the drug and at six- to 12-month intervals thereafter.
Type 1 or 2 diabetics will be able to use the rapid-acting inhaled insulin around mealtimes 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.
Elise Rayner, of Colorado Springs, Colo., said she declined to participate in a clinical trial of inhaled insulin.
"My reaction was, I have excellent control of my blood sugars right now and I just don't have any interest in messing with a good thing," said Rayner, 33, who's used both insulin injections and the pump for her Type 1 diabetes.
Most diabetics have Type 2, a condition linked to obesity that occurs when the body cannot effectively use the insulin it makes. In some cases, the disease can be managed with pills when matched with a diet, exercise and weight-management plan.
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.
Deutsche Bank analyst Barbara Ryan said she expects a daily supply of Exubera will cost about $4 to $5. Treatment with injected insulin costs $1 to $1.50, she said.
WASHINGTON - Diabetics are getting an 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 federal approval, by midyear.
Use of rapid-acting inhaled insulin will not replace the need to inject the hormone occasionally, the Food and Drug Administration said. It approved Exubera on Friday, a day after the multinational European Commission did so.
Diabetics also will have to continue pricking their fingers to test blood sugar levels.
Exubera will provide an option for adults with Type 1 or 2 diabetes who are 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 $1 billion-a-year seller.
The American Diabetes Association estimates that nearly 21 million people in the United States have diabetes and 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 group says.
FDA and Pfizer doctors believe Exubera may encourage diabetics to make more frequent and better use of insulin.
"It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research.
Improved control would allow diabetics to ward off serious complications, including diseases of the eye, kidneys and nerves.
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 allow better dosage control.
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."
An FDA review expressed concern about some patients who experienced coughing or a slight decrease in lung capacity when using the drug. Pfizer will study the long-term effects of Exubera on the lungs, as well as its safety and effectiveness in patients with lung disease.
Diabetics with asthma, poorly controlled or unstable lung disease, or a smoking habit shouldn't use Exubera, the FDA said. Patients should have their lungs checked before using the drug and at six- to 12-month intervals thereafter.
Type 1 or 2 diabetics will be able to use the rapid-acting inhaled insulin around mealtimes 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.
Elise Rayner, of Colorado Springs, Colo., said she declined to participate in a clinical trial of inhaled insulin.
"My reaction was, I have excellent control of my blood sugars right now and I just don't have any interest in messing with a good thing," said Rayner, 33, who's used both insulin injections and the pump for her Type 1 diabetes.
Most diabetics have Type 2, a condition linked to obesity that occurs when the body cannot effectively use the insulin it makes. In some cases, the disease can be managed with pills when matched with a diet, exercise and weight-management plan.
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.
Deutsche Bank analyst Barbara Ryan said she expects a daily supply of Exubera will cost about $4 to $5. Treatment with injected insulin costs $1 to $1.50, she said.
