FDA Approves MannKind’s Inhaled Insulin Product for Adult Diabetics

The Food and Drug Administration June 27 approved Afrezza (insulin human [rDNA origin]) inhalation powder to improve glycemic control in adults with diabetes mellitus.

Afrezza, which is manufactured by Valencia, Calif.-based MannKind Corp., is a rapid-acting inhaled insulin that is administered at the beginning of each meal, or within 20 minutes after starting a meal, the agency said.

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