Editors:Elham Reshid and Hailemariam Shimelis
The Drug Administration U.S. Food and has approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is rapid acting inhaled insulin that is administered at the beginning of each meal. Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin, thus increasing the options available for delivering mealtime (i.e. before or soon after starting to eat) insulin.
The FDA approved Afrezza’s safety and effectiveness based on a study in a total of 3,017 participants–1,026 participants with type 1diabetes 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 injectable insulin), both in combinations with basal insulin (long-acting insulin) in a 24 week study. At week 24, treatment with basal insulin and mealtime Afrezza provided a mean reduction in HbA1c that met the pre-specified non-inferiority margin of 0.4 percent although Afrezza produced significantly less reduction in Hb1Ac compared to Insulin Aspart”.
Afrezza was also studied in adults with type 2 diabetes in combination with oral anti diabetic drugs; the efficacy of mealtime Afrezza in type 2 diabetes patients was compared to placebo inhalation in a 24 week study. Afrezza is not 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.
In the Afrezza clinical trials, the most commonly reported side effects were low blood sugar, cough, and throat pain or irritation, acute bronchospasm in patients with asthma and chronic obstructive pulmonary disease (COPD).
Hence, Afrezza has a Boxed Warning advising that it should not be used in patients with chronic lung disease, such as asthma or COPD because of this risk.
The FDA approved Afrezza with a Risk Evaluation and Mitigation Strategy, which consists of a communication plan to inform health care professionals about the serious risk of acute bronchospasm associated with Afrezza.
The FDA is requiring the following post-marketing studies for Afrezza:
- A clinical trial to evaluate pharmacokinetics, safety and efficacy in pediatric patients;
- A clinical trial to evaluate the potential risk of pulmonary malignancy with Afrezza (this trial will also assess
cardiovascular risk and the long-term effect of Afrezza on pulmonary function);
- Two pharmacokinetic-pharmaco-dynamic euglycemic glucose-clamp clinical trials, one to characterize dose response and one to characterize within-subject variability.
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