FDA Approves Exubera, First Inhalable Form Of Insulin For Controlling Type
1 And Type 2 Diabetes In Adults
Pfizer Inc said that Exubera® (insulin
human [rDNA origin]) Inhalation Powder has been approved by the U.S. Food and
Drug Administration for the treatment of adults with type 1 and type 2 diabetes.
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. Exubera, 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 United States.
a major, first-of-its-kind, medical breakthrough that marks another critical step
forward in the treatment of diabetes, a disease that has taken an enormous human
and economic toll worldwide," said Hank McKinnell, chairman and chief executive
officer of Pfizer. "The global incidence of diabetes is currently at epidemic
levels. Millions of patients are not achieving or maintaining acceptable blood
sugar levels, despite the availability of current therapies. Exubera meets a critical
medical need by offering a highly effective and needle-free alternative to diabetes
pills and insulin injections to manage this complicated, debilitating disease."
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.
The Exubera inhaler weighs four ounces and, when closed, is about the size of
an eyeglass case. The unique Exubera Inhaler 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.
Exubera Meets Medical Need
people who could benefit from insulin are fearful of injections, so they delay
treatment five years or ten 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, a campus of the Louisiana State University System, in Baton Rouge.
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.
"With Exubera, I've been able to control my
blood sugar levels and not constantly worry about how I manage my diabetes,"
said Jamie Villastrigo, a type 2 diabetes patient and Exubera clinical trial participant.
In patients with type 2 diabetes, Exubera can be used alone as an alternative
to rapid-acting insulin injections or diabetes pills, or in combination with diabetes
pills or longer-acting insulin. In patients with type 1 diabetes, Exubera will
be used in combination with longer-acting insulin.
The Burden of Diabetes
in the United States
Complications commonly associated with uncontrolled
or poorly controlled blood sugar levels include heart disease, amputation, blindness
and kidney failure. Diabetes and its complications are estimated to account for
$132 billion in direct and indirect health care costs annually.
21 million Americans have diabetes and approximately 95 percent of these people
have type 2 diabetes.
In type 2 diabetes, the body does not make or use
insulin well enough to manage blood sugar levels. Type 2 diabetes progresses over
time, and eventually most patients will need to administer insulin to achieve
blood sugar control. In type 1 diabetes, the body does not make insulin at all.
These patients must take insulin to survive.
All people with type 1 diabetes
and a large percentage of people with type 2 diabetes need treatment with insulin.
While insulin has been proven to be effective to reduce blood sugar levels and
the risk of complications, health care providers and patients often have been
unwilling to start treatment. Factors include patients' fear of injections and
social embarrassment associated with needles.
Exubera is the result of
one of the most rigorous and innovative diabetes development programs. Pfizer
has invested in two state-of-the-art manufacturing facilities-the world's largest
insulin plants in Frankfurt, Germany, and a highly automated, high-tech production
facility in Terre Haute, Indiana.
Exubera is a product of a collaboration
between Pfizer and Nektar Therapeutics. Pfizer recently reached an agreement to
acquire the sanofi-aventis worldwide rights to Exubera. The two companies were
previously in a worldwide alliance to co-develop, co-promote and co-manufacture
Important Safety Information about Exubera
not take Exubera if they smoke or have stopped smoking less than six months prior
to starting Exubera treatment. If a patient starts smoking or resumes smoking,
he or she must stop using Exubera and see a health care provider about a different
Exubera may affect lung function so patients need to have their
lungs tested before starting Exubera, and periodically thereafter, as directed
by a healthcare provider. The test involves exhaling into a measuring device.
Exubera is not recommended for people that have chronic lung disease (such as
asthma, chronic obstructive pulmonary disease or emphysema). Also, Exubera should
not be used at all by people with unstable or poorly controlled lung disease.
Like all medicines, Exubera can cause side effects. As with all forms of
insulin, a possible side effect of Exubera is low blood sugar levels. Some patients
have reported a mild cough while taking Exubera, which occurred within seconds
to minutes after Exubera inhalation. Coughing occurred less frequently as patients
continued to use Exubera.
Patients and health care providers can call 1-800-EXUBERA
and register to receive more information about Exubera when it is available. The
hotline can be accessed in English.