The US Food and Drug Administration has approved Afrezza (insulin human) Inhalation Powder for children and adolescents aged 6 years and older with type 1 or type 2 diabetes, according to a press release from MannKind Corporation.

Afrezza is an inhaled mealtime insulin administered at the beginning of meals using a small portable inhaler. The product delivers insulin through the lungs via MannKind’s Technosphere drug-delivery platform.

The expanded indication was supported by results from the pivotal phase 3 INHALE-1 trial in pediatric patients, along with additional safety, efficacy, and long-term exposure data from studies evaluating inhaled insulin over more than 2 decades, according to the company.

“Mealtime insulin can be especially challenging for children because eating and snacking patterns, activity levels, and daily settings like school and sports often vary,” said Desmond Schatz, MD, professor of pediatrics at the University of Florida College of Medicine. “With its rapid onset and dosing at the start of a meal, Afrezza may help clinicians better match insulin therapy to how children and families live day to day, while offering a needle-free mealtime option.”

The company said the approval expands Afrezza’s availability beyond adults and introduces a new inhaled mealtime insulin option for pediatric patients and caregivers. MannKind also stated that Afrezza is recognized in the American Diabetes Association Standards of Care alongside multiple daily injections and insulin pumps.

For patients with type 1 diabetes, Afrezza must be used with basal insulin. The product is not indicated for treatment of diabetic ketoacidosis.

Afrezza should not be used in patients with chronic lung disease, including asthma or chronic obstructive pulmonary disease, because of the risk of acute bronchospasm described in the prescribing information. Lung function should be assessed before treatment initiation, 6 months after initiation, and annually thereafter.

The product is not for use in patients who smoke or who have recently stopped smoking within the past 6 months. It is not known whether Afrezza is safe and effective in children younger than 6 years.

The most common adverse reactions include hypoglycemia, cough, and throat pain or irritation. Other warnings and precautions include decreased lung function, lung cancer, diabetic ketoacidosis, severe allergic reaction, hypokalemia, and heart failure when used with thiazolidinediones.

Source: MannKind Corporation