The FDA has approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes. The drug is administered at the start of each meal or within 20 minutes after starting a meal.

“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, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.

The drug’s safety and efficacy were evaluated in a 24-week study that included 3,017 type 1 and type 2 diabetics. At week 24, treatment with Afrezza plus oral anti-diabetic drugs provided a mean reduction in HbA1c that was significantly greater than the reduction observed among placebo recipients.

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According to the FDA, Afrezza is not a substitute for long-acting insulin. It must be used in combination with long-acting insulin in patients with type 1 diabetes, and it is not recommended for treating diabetic ketoacidosis, or in patients who smoke.