The U.S. Food and Drug Administration has approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes.
Afrezza is a rapid-acting inhaled insulin administered at the beginning of each meal or within 20 minutes of starting a meal.
"Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin," said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. "Today’s approval broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels."
Afrezza is not a substitute for long-acting insulin; instead, in patients with type 1 diabetes it must be used in combination with long-acting insulin.
Afrezza comes with a Boxed Warning: some patients with asthma and chronic obstructive pulmonary disease (COPD) have experienced acute bronchospasm after using Afrezza. It should therefore not be used in patients with chronic lung disease, such as asthma or COPD. Otherwise, the most commonly reported side effects reported in clinical trials with Afrezza were hypoglycemia, cough, and throat pain or irritation.
The FDA approved Afrezza with a Risk Evaluation and Mitigation Strategy, which consists of a communication plan to inform health care professionals about the serious risk of acute bronchospasm associated with Afrezza.
On top of that, although FDA approved, the agency is requiring a handful of post-marketing studies for Afrezza:
-- a clinical trial to evaluate pharmacokinetics, safety and efficacy in pediatric patients;
-- a clinical trial to evaluate the potential risk of pulmonary malignancy with Afrezza (this trial will also assess cardiovascular risk and the long-term effect of Afrezza on pulmonary function);
-- two pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, one to characterize dose-response and one to characterize within-subject variability.
Afrezza is not recommended for the treatment of diabetic ketoacidosis, or in patients who smoke.
Photo: Medical Horizons