FDA Approves First Ever Inhaled Insulin Combination Product for Treatment of Diabetes

From FDA News
January 27, 2006

There is a new, potential alternative for many of the more than 5 million Americans who take insulin injections, with the Food and Drug Administration's approval today of the first ever inhaled insulin. Exubera, an inhaled powder form of recombinant human insulin (rDNA) for the treatment of adult patients with type 1 and type 2 diabetes, is the first new insulin delivery option introduced since the discovery of insulin in the 1920s.

"Until today, patients with diabetes who need insulin to manage their disease had only one way to treat their condition," said Dr. Steven Galson, Director, Center for Drug Evaluation and Research, FDA. "It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars."

Diabetes is a disease that affects the amount of insulin and sugar in your body. Exubera is a human form of insulin and as such, lowers blood sugar concentrations by allowing the blood sugar to be taken up by cells as a source of fuel. Exubera is a powdered form of insulin that is able to be inhaled into the lungs through the patient's mouth using a specially designed inhaler.

There are two major types of diabetes — type 1 and type 2. People with type 1 diabetes produce virtually no insulin. In type 2, the most common form of the disease, the body does not produce enough insulin or effectively use insulin. If people with diabetes do not properly control their blood sugar levels, serious complications including heart disease, kidney failure, blindness, and nerve damage may develop.

The safety and efficacy of Exubera have been studied in approximately 2500 adult patients with type 1 and type 2 diabetes. In clinical studies, Exubera reached peak insulin concentration more quickly than some insulins, called regular insulin, administered by an injection. Peak insulin levels were achieved at 49 minutes (range 30 to 90 minutes) with Exubera inhaled insulin compared to 105 minutes (range 60 to 240 minutes) with regular insulin, respectively. In type 1 diabetes, inhaled insulin may be added to longer acting insulins as a replacement for short-acting insulin taken with meals. In type 2 diabetes, inhaled insulin may be used alone, along with oral (non-insulin) pills that control blood sugar, or with longer acting insulins.

Exubera prescriptions will be accompanied by a Medication Guide containing FDA-approved information written especially for patients. Pharmacists are required to distribute Medication Guides with products FDA has determined are important to health, and patient adherence to directions for use is crucial to the product's effectiveness. Patients are advised to read the entire Medication Guide and talk to their healthcare provider if they have further questions.

Like any insulin product, low blood sugar is a side effect of Exubera and patients should carefully monitor their blood sugars regularly. Other side effects associated with Exubera therapy seen in clinical trials included cough, shortness of breath, sore throat, and dry mouth.

Exubera is not to be used if you smoke or if you recently quit smoking (within the last 6 months). Exubera is not recommended in patients with asthma, bronchitis, or emphysema. Baseline tests for lung function are recommended before beginning treatment and are recommended to be repeated every 6 to 12 months thereafter.

While Exubera has been extensively studied for safety, the sponsor has committed to performing long-term studies to confirm the continued safety of Exubera after it is marketed and to examine more thoroughly the issue of the efficacy and safety of Exubera in patients with underlying lung disease.

Exubera is manufactured by Pfizer Inc., NY, NY.

Media Inquiries:
Laura Alvey, 301-827-6242
Consumer Inquiries: 888-INFO-FDA

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