Exubera Approval

Armen Hareyan's picture
Advertisement

Exubera and Diabetes

FDA today approved first ever inhaled insulin, called Exubera. 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.

Advertisement

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.

Advertisement