FDA Approves Novel Inhaled Insulin

Posted by The Evidence Blog on July 3, 2014

The Food and Drug Administration has approved Afrezza Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is administered at the beginning of each meal. Afrezza is approved for patients with both type 1 and type 2 diabetes but does not replace the need for basal (long-acting) insulin.

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.

Because it is an inhaled medication, there is concern about pulmonary function. 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—or in patients who have lung cancer 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 healthcare professionals about the serious risk of acute bronchospasm associated with Afrezza. The manufacturer is also required to conduct several postmarketing studies to evaluate: 1) safety and efficacy in children; 2) potential risk of pulmonary function and cardiovascular risk; and 3) two euglycemic glucose-clamp clinical trials.

  1. Food and Drug Administration (FDA). FDA approves Afrezza to treat diabetes [news release]. Issued June 27, 2014. Updated June 30, 2014. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm403122.htm. Accessed July 3, 2014.

Topics: Hayes Blog

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