US advisers back Pfizer's inhaled insulin

Pfizer Inc.'s inhaled insulin powder Exubera neared U.S. approval on Thursday after scientific advisers said it could substitute for some of the injections many diabetics need to control blood sugar.

An advisory panel voted 7-2 to urge the Food and Drug Administration to approve Exubera for adults with Type 1 Diabetes, which occurs when the body produces little or no insulin to control blood sugar, or Type 2 diabetes, when the body does not properly use insulin.

Diabetics can prevent complications such as Heart disease, Blindness and amputations with a healthy diet, exercise, oral medications or insulin shots.

But many people are wary of needles and avoid taking insulin shots multiple times per day, Pfizer representatives and some panel members said.

Exubera is a short-acting form of insulin that diabetics could take before meals. Many patients still would need to take long-acting insulin by injection.

If Exubera goes to market, "this does not mean diabetics can throw away their needle and syringe," stressed Dr. Paul Woolf, the panel's acting chairman and an endocrinologist at Crozer Chester Medical Center in Upland, Pennsylvania.

Woolf voted against Exubera because he said he was not convinced patients would get adequate training in how to use the insulin inhaler properly.

The FDA will consider the panel's advice. While the agency is not required to follow advisory panel recommendations, it usually does.

Exubera's approval has been held up over concerns it might hamper lung function. In clinical studies, patients experienced a small decrease in lung capacity in the initial weeks of treatment. The changes did not worsen during two years of study and were reversible if Exubera was stopped, Pfizer said.

Exubera patients were more likely to report coughing but most cases were mild, Pfizer and FDA officials said.