DJ's coverage of the previous PR...
Pfizer: Exubera Data Show Small, Reversible Lung Changes
WASHINGTON -(Dow Jones)- Results from two ongoing clinical studies of Pfizer
Inc.'s (PFE) inhaled insulin drug, Exubera, showed that small declines in lung
function reversed when the drug was stopped, the company said.
Results from the studies involving Exubera are scheduled to be presented
Monday at the American Diabetes Association's annual meeting in Chicago.
Exubera, a needle-free product, was approved by the U.S. Food and Drug
Administration last year and can replace short-acting insulin shots taken by
people with Type 1 diabetes and some patients with Type 2 diabetes. Some
patients, however, still require a longer-acting insulin injection in order to
control the body's blood sugar levels.
One of the main concerns the FDA had about Exubera involves pulmonary safety
because the insulin is absorbed by the lungs rather than under the skin, so
Pfizer's been studying the effect of the drug on patient's lungs.
The new data involves about 1,200 patients who've been followed for three
years. Overall the studies found that any declines in lung function were small,
occurred early in treatment and didn't get any worse over time.
Patients were either given standard insulin injections or Exubera for two
years. Then all patients received injected insulin for six months and then for
another six months some patients started receiving Exubera again. Any declines
in the lung function of Exubera users reversed a month after stopping Exubera.
When Exubera was started again, lung-function declines were also small and were
similar to the changes seen among first-time users of Exubera.
The studies also showed Exubera controlled blood sugar in a similar manner to
those using injected insulin and that Exubera patients generally gained less
weight than those receiving injections, Pfizer said.
It's recommended that people using Exubera undergo baseline tests for lung
function before beginning treatment and then periodically during treatment.
When Exubera was first approved, many analysts had predicted Exubera could
reach blockbuster status with annual sales of $1 billion or more. So far Pfizer
has said it's been "disappointed" with sales, but plans to start a broader
promotion of the drug later this summer.
About 21 million Americans have diabetes, a disease characterized by high
blood-glucose levels that result from the body's inability to use or produce
insulin. Type 2 diabetes most often occurs in people who are older than 45 and
overweight, although there has been an increase in younger patients in recent
years.
Type 1 diabetes, often diagnosed in childhood, requires people to use insulin
to manage their blood sugar levels. Many diabetics also have poor lipid
profiles, which puts them at risk for cardiovascular disease. Diabetes also can
lead to blindness, kidney disease and amputations.
-By Jennifer Corbett Dooren |
