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Inhaled insulin may get US FDA clearance

Powdered insulin could get rid of painful needle pricks for millions of diabetics



13 September,2005: A welcome alternative to insulin pricks, the inhaled form of insulin has been recommended for approval by federal drug regulator.

An advisory panel to the Food and Drug Administration voted 7 to 2 to recommend approval of the drug for adults with either type 1 or type 2 diabetes. If approved, the drug will provide relief from daily dose of insulin injections that millions of diabetics in the US resort to, to control their blood sugar levels. 

Chief concerns about the drug involve its long-term effects on the lungs, as well as whether it is safe and effective on people who smoke or have lung disease, according to documents released by the Food and Drug Administration. The product, called Exubera, was developed by Pfizer in partnership with Sanofi-Aventis of France and Nektar Therapeutics, a California biotechnology firm. 

Data presented by Pfizer showed that Exubera was equivalent to injected insulin in controlling blood sugar, but not superior. 

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

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.

Some 18 million Americans 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. 

Inhalable insulin is delivered from a device that creates a cloud of powdered form of the drug. It would be taken at mealtimes and could replace the short-acting insulin typically injected then. 

FDA has been sitting over the Pfizer's application for at least two years waiting for more safety data after patients in earlier clinical trials experienced a small decline in lung function compared with those in the comparison group. Pfizer also stopped testing the drug in children, with the result that the company is not currently seeking approval for children's use. 

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee backed that finding in cases of people with healthy lungs. But in response to a question by the F.D.A., the panel voted 5 to 4 that safety had not been established for patients with lung diseases. 

Intake of the drug too is somewhat complicated. Only about 10 percent of the inhaled insulin makes it into the bloodstream and the amount can vary depending on the patient's health and inhalation technique. 

Inhaling three one-milligram packs of Exubera in succession produces a different effect than using one 3-milligram pack. Smokers tend to absorb several times as much drug into their bloodstream as nonsmokers. For that reason, Pfizer proposes that the drug not be approved for smokers. Some panel members urged more study on blood levels in those exposed to secondhand smoke. 

Analysts have estimated that Exubera sales could easily exceed $1 billion within a few years. Others are also developing inhaled insulin. Closest behind is Eli Lilly & Company, working with the biotechnology company Alkermes. Others include Novo Nordisk, the Danish insulin manufacturer, and MannKind, a California start-up. 



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