RespiteMatch.com Health Blog

By Andrew Pollack The New York Times

FRIDAY, SEPTEMBER 9, 2005

NEW YORK The first inhaled form of insulin, a product that could reduce or eliminate the daily injections needed by millions of diabetics, has moved closer to approval in the United States.

An advisory panel to the U.S. Food and Drug Administration voted 7-to-2 on Thursday to recommend approval of the drug for adults with either type 1 or type 2 diabetes, despite some concerns about the long-term impact that inhaling insulin would have on users’ lungs.

The product, called Exubera, was developed by Pfizer in partnership with Sanofi-Aventis and Nektar Therapeutics, a California biotechnology firm.

The FDA, sensitive to recent criticism that it has been lax on safety, must still make a final ruling. The regulator often, but not always, follows the advice of its advisory committees, which are made up of outside experts.

Because Exubera is a novel product that would be taken for years, it is conceivable the agency will ask for more data, especially given the questions about its effect on the lungs and the fact that Exubera’s advantage over injected insulin is mostly convenience. Data presented by Pfizer showed that Exubera was equivalent to injected insulin in controlling blood sugar levels, but not superior.

Pfizer and its consultants argued that approval of Exubera could enhance public health by encouraging more people to use insulin, which would improve control of their blood sugar. Keeping glucose levels down has been shown to reduce long-term complications of diabetes like cardiovascular problems and kidney disease.

“There’s resistance to use of insulin,” at least partly because people fear injections, said Dr. William Cefalu, a professor at Louisiana State University who spoke on behalf of Pfizer. Fewer than a third of people with type 2 diabetes use insulin, he said, but many more could benefit because two-thirds of diabetics do not control blood glucose as tightly as experts recommend.

In the United States alone, about 18 million people are estimated to have diabetes, although several million of them may not know it. At least 90 percent have type 2 diabetes, which is often associated with obesity and usually begins in adulthood. The others have type 1, formerly called juvenile diabetes.

NEW YORK The first inhaled form of insulin, a product that could reduce or eliminate the daily injections needed by millions of diabetics, has moved closer to approval in the United States.

An advisory panel to the U.S. Food and Drug Administration voted 7-to-2 on Thursday to recommend approval of the drug for adults with either type 1 or type 2 diabetes, despite some concerns about the long-term impact that inhaling insulin would have on users’ lungs.

The product, called Exubera, was developed by Pfizer in partnership with Sanofi-Aventis and Nektar Therapeutics, a California biotechnology firm.

The FDA, sensitive to recent criticism that it has been lax on safety, must still make a final ruling. The regulator often, but not always, follows the advice of its advisory committees, which are made up of outside experts.

Because Exubera is a novel product that would be taken for years, it is conceivable the agency will ask for more data, especially given the questions about its effect on the lungs and the fact that Exubera’s advantage over injected insulin is mostly convenience. Data presented by Pfizer showed that Exubera was equivalent to injected insulin in controlling blood sugar levels, but not superior.

Pfizer and its consultants argued that approval of Exubera could enhance public health by encouraging more people to use insulin, which would improve control of their blood sugar. Keeping glucose levels down has been shown to reduce long-term complications of diabetes like cardiovascular problems and kidney disease.

“There’s resistance to use of insulin,” at least partly because people fear injections, said Dr. William Cefalu, a professor at Louisiana State University who spoke on behalf of Pfizer. Fewer than a third of people with type 2 diabetes use insulin, he said, but many more could benefit because two-thirds of diabetics do not control blood glucose as tightly as experts recommend.

In the United States alone, about 18 million people are estimated to have diabetes, although several million of them may not know it. At least 90 percent have type 2 diabetes, which is often associated with obesity and usually begins in adulthood. The others have type 1, formerly called juvenile diabetes.