Saturday, January 28, 2006

Pfizer Receives FDA Approval for Exubera, the First Inhalable Form of Insulin for Controlling Type 1 and Type 2 Diabetes in Adults

This should be welcome news to the milions of diabetes sufferers, however it's important to note the following cautions as stated in the press release:

"Exubera may affect lung function so patients need to have their lungs tested before starting Exubera, and periodically thereafter, as directed by a healthcare provider. The test involves exhaling into a measuring device. Exubera is not recommended for people that have chronic lung disease (such as asthma, chronic obstructive pulmonary disease or emphysema). Also, Exubera should not be used at all by people with unstable or poorly controlled lung disease."

NEW YORK, January 27 -- Pfizer Inc said today that Exubera® (insulin human [rDNA origin]) Inhalation Powder has been approved by the U.S. Food and Drug Administration for the treatment of adults with type 1 and type 2 diabetes. Exubera was found in clinical trials to be as effective as short-acting insulin injections, and to significantly improve blood sugar control when added to diabetes pills. Exubera, which is expected to be available for patients by mid-year, 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.

"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, chairman and chief executive officer of Pfizer. "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 rapid-acting, dry powder human insulin that is inhaled through the mouth into the lungs prior to eating, using the handheld Exubera Inhaler. The Exubera inhaler weighs four ounces and, when closed, is about the size of an eyeglass case. The unique Exubera Inhaler produces in its chamber a cloud of insulin powder, which is designed to pass rapidly into the bloodstream to regulate the body's blood sugar levels.

Exubera Meets Medical Need

"Many people who could benefit from insulin are fearful of injections, so they delay treatment five years or ten years, placing them at risk for serious complications. Now, for the first time patients can improve blood sugar control with fewer or no painful injections," said Dr. William Cefalu, Exubera investigator and chief of the division of nutrition and chronic diseases at the Pennington Biomedical Research Center, a campus of the Louisiana State University System, in Baton Rouge... Full News Release

1 comment:

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