The first inhaled insulin for children

At the end of May, the American company MannKind received FDA approval for Afrezza for use in children. It is the first and only inhaled insulin for patients over six years of age with diabetes. The drug was first approved for use in adults (over 18) in 2014. 

Diabetes mellitus is a chronic disease that impairs blood sugar control. Diabetes can be:

• Type 1: A condition in which the immune system destroys the cells that produce insulin, requiring regular injections of this hormone.

• Type 2: A condition in which cells stop responding to insulin. Some patients are also prescribed insulin injections over time. 

Insulin is a hormone that regulates blood glucose levels. 

One of the common and dangerous problems of uncontrolled diabetes is hyperglycemia, or elevated blood glucose (sugar) levels. This slow but destructive effect over time causes serious damage to many body systems, particularly the nerves and blood vessels. 

Afrezza is an inhaled insulin powder that is inhaled before meals. It acts very quickly: it enters the bloodstream within a minute, lowers blood sugar within 12 minutes, and lasts for 1.5 to 3 hours. This mimics the body's natural response, unlike subcutaneous insulins, which act more slowly (starting to work within 15 to 30 minutes, and the effect lasts up to 5 hours). 

Afrezza demonstrated comparable efficacy to injectable forms in the Phase III INHALE-1 clinical trial. However, inhaled insulin can only be used to cover mealtime insulin requirements. It is particularly noted that Afrezza does not create a long-term supply of the hormone, so people with type 1 diabetes will need to take long-acting insulin injections. 

This drug is contraindicated: 

• Patients with chronic lung diseases due to the risk of bronchospasm and acute respiratory failure. 

• People who smoke or have quit smoking less than 6 months ago. 

Common side effects include hypoglycemia (low blood sugar, as with all insulins) and a temporary cough after inhalation.

Some isolated cases of lung cancer were identified among those taking Afrezza during studies.

Insured Americans can purchase this medication for $35. Without insurance, the drug costs $99.