DOC News December 1, 2007
Volume 4 Number 12 p. 5
© 2007 American Diabetes Association
Weak Sales Lead to Exubera's Market Withdrawal
Pfizer pulls the first pulmonary insulin, but others are in the
works
Andrew Keegan
When the first inhalable insulin, Exubera, was approved for use by the U.S.
Food and Drug Administration in January 2006, many anticipated that the
product would revolutionize diabetes care by offering an alternative to
insulin injections. But less than 2 years later, after sales paled in
comparison to the billion-dollar payoff the company had been expecting,
manufacturer Pfizer Inc. is taking Exubera off the market.
An October 18 statement from the company's chief medical officer, Joseph
Feczko, MD, attributes this step to the fact that "too few patients are
taking Exubera" and that other glucose-lowering alternatives exist.
Pfizer says that the decision was not the result of any safety concerns and
that the drug will remain available into January, to enable adequate time for
those taking it to talk with their doctors about treatment options.
Why did a product with so much potential—and so many research dollars
behind it—fail? The short answer is that neither people with diabetes
nor care providers embraced the technology. Some resisted Exubera's bulky
delivery system. Others may have had safety concerns: Exubera was found to
cause a slight decline in lung capacity during the first 3 months of use
(DOC News, September 2007, page 1). Lung tests were required before
initiating Exubera, with further tests recommended after the first 6 months of
therapy. The inconvenience and expense of this additional testing may have
further slowed acceptance of this product.
Furthermore, recent advances in needle technology that have made insulin
injections much less onerous and virtually painless further reduced the demand
for an inhaled product. Exubera also was more expensive than injected insulin.
Finally, because Exubera was a rapid-acting mealtime insulin, people who use
longer-acting insulins still were required to inject as part of their
routine.
Exubera was the only inhalable insulin on the market, but other companies
are developing their own versions. Eli Lilly's AIR Insulin System, Mann-Kind's
inhaled Technosphere Insulin, and Novo Nordisk's AERx insulin Diabetes
Management System are three such examples; all are in Phase III trials. It's
not known what effect, if any, Exubera's failure will have on the development
of these products. 
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