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FDA Approves Diabetes Inhaler Exubera

January 27, 2006

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The U.S. Food and Drug Administration approved Exubera, Pfizer’s inhaled human insulin, for the treatment of adults with type 1 and type 2 diabetes. The European Commission had also approved the drug earlier Friday.

The company created some confusion in making the announcement Friday morning when it told business cable TV channel CNBC that it had received FDA approval, an announcement that turned out to be a few hours premature. The FDA approval came through later Friday.

Exubera is the first non-injectable, inhalable form of insulin to be approved since the discovery of insulin in the 1920s, and Pfizer is promoting it as a major advance in diabetes treatment.

According to the World Health Organization (WHO), diabetes has reached epidemic proportions and affects approximately 48 million people in Europe alone.

People with diabetes often suffer from debilitating complications due to uncontrolled blood sugar levels including heart disease, amputation, blindness and kidney failure. The direct healthcare costs associated with diabetes are estimated to be around $286 billion worldwide, with the majority of these costs linked to treating diabetes-related complications.

Since its discovery more than 80 years ago, insulin has been the preferred treatment for diabetes. In order to achieve tight blood sugar control, insulin is often administered before meals to mimic the body's natural insulin response to food.

But healthcare providers and patients are often reluctant to initiate or intensify insulin therapy when it is required due to the need for daily injections.

"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," said Hank McKinnell, Pfizer chairman and chief executive officer.

"The global incidence of diabetes is currently at epidemic levels. Millions of patients are not achieving or maintaining acceptable blood sugar levels, despite the availability of current therapies. 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 a dry powder formulation of human insulin that is inhaled into the lungs via the mouth before meals using a simple-to-use, hand-held device that does not require batteries or electricity.

The device, which weighs four ounces and is about the size of a carrying case for a pair of eye glasses, is designed to deliver an accurate dose of insulin each time it is used.

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