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Afrezza Receives FDA Approval to Treat Diabetes

Inhaled insulin is used at the start of a meal

The FDA has approved a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza (insulin human inhalation powder, MannKind Corporation) is administered at the beginning of each meal.

Afrezza’s safety and effectiveness were evaluated in 3,017 participants —1,026 with type 1 diabetes and 1,991 patients with type 2 diabetes.

The efficacy of mealtime Afrezza in adults 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. At week 24, treatment with basal insulin and mealtime Afrezza provided a mean reduction in hemoglobin A1c (HbA1c) that met the prespecified noninferiority margin of 0.4%. Afrezza provided less HbA1c 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 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 HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group.

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.

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.

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 the drug. The FDA is also requiring the following postmarketing 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-pharmacodynamic euglycemic glucose-clamp clinical trials, one to characterize dose response and one to characterize within-subject variability.

An estimated 25.8 million people in the United States — approximately 8.3% of the population — have diabetes; 18.8 million have been diagnosed and 7.0 million remain undiagnosed. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.

Source: FDA; June 27, 2014.

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