FDA Advisory Committee Recommends Approval of Exubera for Diabetes

NEW YORK, September 8, 2005 -- Pfizer Inc and the sanofi-aventis Group said today that a U.S. Food and Drug Administration advisory committee has recommended the approval of Exubera (insulin [rDNA origin] powder for oral inhalation), an inhalable, rapid-acting, dry powder insulin for the treatment of adults with Type 1 and Type 2 diabetes.

Exubera, a joint-development program between sanofi-aventis and Pfizer, is a form of insulin that is inhaled through the mouth into the lungs prior to eating, using a proprietary inhalation device and powdered insulin formulation developed by Nektar Therapeutics. Exubera closely mimics the normal physiological insulin response to meals by quickly being absorbed into the bloodstream to reduce meal-related spikes in glucose levels in people with diabetes.

The FDA is not obligated to follow the recommendations of the panel.

In the United States, approximately 18 million people suffer from diabetes, with type 2 diabetes accounting for 90 percent to 95 percent of all diagnosed cases. A recent report shows that 67 percent of Americans with type 2 diabetes have blood sugar levels that are not controlled and are above the recommended national treatment guidelines. Although insulin is the definitive treatment for diabetes, health care providers and patients are often reluctant to initiate or intensify insulin treatment. The reasons for this include concerns about lifestyle changes, compliance, disease progression and injection-related factors. Many individuals may delay insulin use for as many as five to ten years.

Complications commonly associated with uncontrolled or poorly controlled diabetes include cardiovascular disease, kidney failure and blindness. Diabetes and its complications are estimated to account for $132 billion in direct and indirect health care costs annually in the United States.

Pfizer and sanofi-aventis said that the companies will continue to work with the FDA to make Exubera available for patients in need. Pending FDA approval, Exubera would represent a major advance in insulin delivery and would be the first non-injectable insulin available in the United States since the discovery of insulin in the 1920s.

Source: Pfizer Inc

Posted: September 2005


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