Pfizer receives US approval for Exubera

The decision by the US regulators comes shortly after the treatment was approved in Europe.

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.

The drug, 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 US.

“Many people who could benefit from insulin are fearful of injections, so they delay treatment five years or 10 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.

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 which 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.

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.

In clinical trials, many patients using Exubera reported greater treatment satisfaction than patients taking insulin by injection. Significantly more patients who had used both Exubera and insulin injections or diabetes pills reported an overall preference for Exubera.

Analysts suggest that Exubera will achieve sales of over $1 billion per year – a figure the company says it has invested into the development of the treatment.