FDA approves rapid-acting insulin inhalation powderNews - July 1, 2014
The American Food and Drug Administration has approved Human Insulin Inhalation Powder, as a new treatment option for patients with diabetes requiring mealtime insulin. It is a rapid-acting inhaled insulin to improve glycaemic control in adults, which should be administered at the beginning of each meal.
The drug’s safety and effectiveness were evaluated in a total of 3017 participants– 1026 participants with type 1 diabetes and 1991 patients with type 2 diabetes. The efficacy of mealtime inhaled insulin 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. At week 24, treatment with basal insulin and mealtime inhaled insulin provided a mean reduction in HbA1c that met the pre-specified non-inferiority margin of 0.4 percent. Inhaled insulin provided statistically significantly less HbA1c reduction than insulin aspart.
Inhaled insulin was studied in adults with type 2 diabetes in combination with oral antidiabetic drugs. At week 24, treatment with inhaled insulin plus oral antidiabetic drugs provided a statistically significantly greater mean reduction in HbA1c, as compared to the HbA1c reduction observed in a placebo group.
Inhaled insulin is not a substitute for long-acting insulin. The insulin inhalation powder 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.
Inhaled insulin has a Boxed Warning advising that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD). Inhaled insulin 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 inhaled insulin in clinical trials were hypoglycaemia, cough, and throat pain or irritation.
The FDA approved inhaled insulin 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 inhaled insulin. Post-marketing studies on the use in pediatric patients, the potential risk of pulmonary malignancies and on pharmacokinetics and pharmacodynamics are required.
SourcePress release FDA June 23 2014