Inhaled Insulin Gets FDA OK
Exubera Will Provide Alternative to Insulin Injections for Diabetes Patients
Why Inhaled Insulin? continued...
That's where short-acting insulin shots come in. But it's no fun taking all
those shots. That's why many people with diabetes put off starting insulin or
don't take it as often as they should.
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
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
"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
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
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.