FDA Approves First-Ever Inhaled Insulin Product


The Food and Drug Administration (FDA) has approved Afrezza Inhalation Powder, the first-ever inhaled insulin product to receive approval in the United States. "Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin," said Dr. Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products at the FDA’s Center for Drug Evaluation and Research, in a press release. “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.”

While the FDA’s Afrezza trials found it to be effective in treating both type 1 and type 2 diabetes, the agency warned that the product cannot be used to replace long-acting insulin. Rather, Afrezza must be used in conjunction with long-acting insulin for type 1 diabetes patients and with oral anti-diabetic drugs for type 2 diabetes patients.

Read more about Afrezza in the FDA’s press release.