Pfizer receives FDA approval for Exubera inhalable insulin for diabetes

By Lisa Kerner

Erie, Pa., Jan. 27 - Pfizer Inc said Exubera (insulin human [rDNA origin]) Inhalation Powder has been approved by the Food and Drug Administration for the treatment of adults with type 1 and type 2 diabetes.

Exubera is expected to be available for patients by mid-year. It is the first inhaled form of insulin and the first insulin option that does not need to be administered by injection in the United States, according to a company news release.

Pfizer said in clinical trials Exubera was found to be as effective as short-acting insulin injections, and to significantly improve blood sugar control when added to diabetes pills. The efficacy and safety profile of Exubera was studied in more than 2,500 adults with type 1 or type 2 diabetes for an average duration of 20 months.

Exubera is a rapid-acting, dry powder human insulin that is inhaled through the mouth into the lungs using the handheld Exubera Inhaler. The unique Exubera Inhaler produces a cloud of insulin powder designed to pass rapidly into the bloodstream to regulate blood sugar levels.

In patients with type 2 diabetes, Exubera can be used alone as an alternative to rapid-acting insulin injections or diabetes pills, or in combination with diabetes pills or longer-acting insulin. In patients with type 1 diabetes, Exubera will be used in combination with longer-acting insulin, the company said.

"Exubera is a major, first-of-its-kind, medical breakthrough that marks another critical step forward in the treatment of diabetes, a disease that has taken an enormous human and economic toll worldwide," Hank McKinnell, chairman and chief executive officer of Pfizer, said in the release. "Exubera meets a critical medical need by offering a highly effective and needle-free alternative to diabetes pills and insulin injections to manage this complicated, debilitating disease."

Exubera is the result of collaboration between Pfizer and Nektar Therapeutics. Pfizer recently reached an agreement to acquire the sanofi-aventis worldwide rights to Exubera.

New York-based Pfizer engages in the discovery, development, manufacture and marketing of prescription medicines.

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