FDA approves rapid-acting, inhaled insulin for diabetes

FDA approved insulin human Inhalation Powder (Afrezza, MannKind), a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus.

It is administered at the beginning of each meal, or within 20 minutes after starting a meal.

"The recently FDA-approved inhaled insulin for diabetes management, Afrezza, is a tremendous breakthrough in the diabetes community as it provides an alternative to the existing injection route of administration,” said Clarence D. Moore, PharmD, BCPS, assistant professor, department of clinical and administrative pharmacy sciences, Howard University College of Pharmacy, Washington, D.C. “This innovative route of administration may contribute to improved compliance in patients diagnosed with the disease who could possibly be deterred by the necessary frequent injections of required insulin."

Afrezza’s safety and effectiveness were evaluated in 3,017 participants, including 1,026 participants with type 1 diabetes and 1,991 patients with type 2 diabetes. The efficacy of mealtime Afrezza in adult patients with type 1 diabetes patients was compared to mealtime insulin aspart (fast-acting insulin), both in combination with basal insulin (long-acting insulin) in a 24-week study, according to an FDA press release. At week 24, treatment with basal insulin and mealtime Afrezza provided a mean reduction in HbA_1c that met the pre-specified non-inferiority margin of 0.4%. Afrezza provided less HbA_1c reduction than insulin aspart, and the difference was statistically significant. Afrezza was studied in adults with type 2 diabetes in combination with oral antidiabetic drugs; the efficacy of mealtime Afrezza in type 2 diabetes patients was compared to placebo inhalation in a 24-week study. At week 24, treatment with Afrezza plus oral antidiabetic drugs provided a mean reduction in HbA_1c that was statistically significantly greater compared to the HbA_1c reduction observed in the placebo group.

Afrezza cannot be a substitute for long-acting insulin. Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes, and it is not recommended for the treatment of diabetic ketoacidosis, or in patients who smoke.

Afrezza has a Boxed Warning advising that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD). Afrezza should not be used in patients with chronic lung disease, such as asthma or COPD because of this risk. The most common adverse reactions associated with Afrezza in clinical trials were hypoglycemia, cough, and throat pain or irritation.

FDA approved Afrezza with a Risk Evaluation and Mitigation Strategy, which consists of a communication plan to inform healthcare professionals about the serious risk of acute bronchospasm associated with Afrezza.

“The FDA approval of Afreeza offers a unique delivery system for insulin and provides another option to the arsenal of agents that individuals with diabetes can use to effectively manage their condition,” said said Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala.

Diabetes mellitus affects 29.1 million people in the United States, according to the Centers for Disease Control and Prevention.