FDA Approves Inhaled Insulin

Exubera Will Provide Alternative To Insulin Injections For Diabetes Patients

(WebMD) 
A wide range of alternatives is under development. They include insulin mouth sprays, insulin patches, and even forms of insulin that can be swallowed. And other companies -- notably a collaboration between Eli Lilly & Co. and Alkermes Inc. -- are racing to develop their own versions of insulin inhalers.

Exubera will be the first of these products to reach the market. Some analysts -- pointing to the ongoing diabetes epidemic and the fact that 7% of Americans have diabetes -- say it will be a sales blockbuster.

Whether or not sales reach the billion-dollar level, diabetes experts welcome the new products. One of them is Robert Rizza, MD, president of the American Diabetes Association and professor at the Mayo Clinic College of Medicine.

"Anything that makes insulin simpler and easier to take is a major step forward," Rizza told WebMD in a June 2005 interview. "Many people's blood sugars are higher than need be. But they wait too long to start taking insulin and subject their bodies to harm. So anything that allows you to control your blood sugar sooner is likely to be a benefit."

Concern Over Lung Safety

The FDA approval of Exubera follows a 7-2 vote recommending approval by a panel of expert advisors. The advisory panel -- in a 5-4 vote -- also called for new studies of Exubera's long-term safety in people with underlying lung disease.

The FDA's approval requires the manufacturer to perform long-term studies to confirm Exubera's safety.

The drug is approved for people with type 1 diabetes and people with type 2 diabetes who need insulin to keep their blood sugar under control. However, clinical trials found that fewer than 30% of people with type 1 diabetes were able to reduce their blood sugar to recommended levels after six months on Exubera.

Pfizer and Sanofi-Aventis did not seek FDA approval for Exubera in children and teens. Early trials in children were stopped due to concerns about Exubera's effects on children's breathing. The companies plan to restart pediatric studies after consultation with the FDA.

The European Union yesterday approved Exubera for treatment of type 1 and type 2 diabetes in adults.

Sources: News release, FDA. WebMD Medical News: "FDA Panel Urges Approval of Inhaled Insulin," Sept. 8, 2005. Robert Rizza, MD, president, American Diabetes Association, interviewed June 16, 2005. FDA. Pfizer/Sanofi Aventis.