FDA Approves Afrezza for Diabetes Control at Mealtime

New inhaled insulin treatment gets FDA approval for mealtime blood sugar control

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) The US Food and Drug Administration has approved a new medication to improve blood sugar control in adults with diabetes.

The new medication is called Afrezza (insulin human) Inhalation Powder. Afrezza is a rapid-acting inhaled insulin used at the start of each meal or within 20 minutes of beginning a meal.

Insulin is a naturally occurring hormone that helps to manage blood sugar levels. In people with diabetes, the body either does not produce insulin (type 1 diabetes) or does not respond properly to insulin (type 2 diabetes). Blood sugar can rise to potentially harmful levels in these patients, especially after eating a meal.

Afrezza, and other fast-acting insulins, are used to correct high blood sugar during meals and snacks.

"Ask your pharmacist about recently approved treatments to control diabetes."

"Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin," said Jean-Marc Guettier, MD, 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," Dr. Guettier said.

This approval comes after Afrezza was tested for safety and effectiveness in a total of 1,026 people with type 1 diabetes and 1,992 people with type 2 diabetes.

In a 24-week study on adults with type 1 diabetes, researchers compared the effectiveness of Afrezza to that of mealtime insulin aspart (fast-acting insulin), both in combination with basal insulin (long-acting insulin).

According to the FDA, type 1 diabetes patients treated with Afrezza had a reduction in HbA1c (a measure of blood sugar control) that was lower than that provided by insulin aspart.

In the trial on patients with type 2 diabetes, the researchers compared Afrezza plus oral antidiabetic medications to a placebo (fake medication).

The FDA reported that the type 2 diabetes patients treated with Afrezza and oral antidiabetic medications had a greater average reduction in HbA1c than those who received placebo.

According to the FDA, Afrezza is not a replacement for long-acting insulin. In patients with type 1 diabetes, Afrezza must be used in combination with long-acting insulin. The treatment is recommended in patients who smoke or to treat diabetic ketoacidosis (when the body burns fatty acids for energy instead of sugar).

Afrezza carries a Boxed Warning explaining that researchers have seen acute broncospasm in patients with asthma and COPD (chronic obstructive pulmonary disease). In light of this risk, the FDA says that Afrezza should not be used in people with lung diseases like asthma and COPD.

The most commonly reported negative side effects linked to Afrezza have been hypoglycemia (when blood sugar drops too low), cough and throat pain or irritation.

Review Date: 
June 27, 2014
Last Updated:
June 30, 2014