News Feature | July 1, 2014

FDA Approves Inhaled Insulin Afrezza For Diabetes

By Estel Grace Masangkay

The U.S. Food and Drug Administration (FDA) has granted approval to MannKind Corporation’s Afrezza (insulin human) Inhalation Powder for the improvement of glycemic control in adult patients with diabetes mellitus.

Afrezza is a fast-acting inhaled insulin comprised of Afrezza Inhalation Powder delivered via an inhaler. The drug is administered at the start of a meal and delivers insulin quickly to the bloodstream after being dissolved in the deep lung. Afrezza achieves peak insulin levels within 12 to 15 minutes of administration which decline to baseline in about 180 minutes.

“Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin. 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,” said Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.

Alfred Mann, CEO of MannKind Corporation, said that the approval is a crucial milestone for the company. “We are excited for patients, as we believe that AFREZZA's distinct profile and non-injectable administration will address many of their unmet needs for mealtime insulin therapy, and has the potential to change the way that diabetes is treated.”

Diabetes affects approximately 25.8 million people in the U.S. alone, of which 18.8 million are diagnosed and 7 million are still undiagnosed. The disease can increase the risk of serious complications such as heart disease, blindness, and nerve and kidney damage over time.

The approval of Afrezza was supported by safety and efficacy data in a 24-week study, where the drug together with basal insulin achieved a statistically significant mean reduction in HbA1c in patients with Type 2 diabetes.

The FDA reported that it approved Afrezza with a Risk Evaluation and Mitigation Strategy to ensure that the serious risk of acute bronchospasm associated with the use of the drug is outweighed by its benefits for patients.