FDA clears Afrezza inhaled insulin for children 6 and older
The expanded approval gives pediatric diabetes patients a rapid-acting mealtime insulin option delivered through the lungs.
By Priya Raghavan · Science Reporter
2 min read
The U.S. Food and Drug Administration has approved Afrezza, an inhaled insulin powder, for children and teenagers age 6 and older with type 1 or type 2 diabetes, HealthDay reported. The decision expands a rapid-acting mealtime treatment that had already been cleared for adults.
Afrezza is insulin human inhalation powder, according to HealthDay. MannKind, the company behind the product, received the expanded approval for pediatric use.
HealthDay reported that Afrezza is designed to be used when a person eats. The product delivers insulin through the lungs, using MannKind’s Technosphere drug-delivery platform, which the company says allows insulin to be absorbed quickly.
For children and adolescents with diabetes, the approval adds an option that does not require a mealtime injection, according to MannKind’s statement cited by HealthDay. The company described the product as a way to match insulin dosing more closely with eating.
The FDA’s decision was supported by findings from the phase 3 INHALE-1 study in pediatric patients, HealthDay reported. Regulators also considered clinical efficacy and safety evidence involving Technosphere inhaled insulin collected across more than 20 years and thousands of patients, according to the report.
Michael Castagna, MannKind’s chief executive officer, said the approval could change how some families handle mealtime insulin. “For more than a century, insulin therapy for children living with diabetes has largely meant multiple daily injections,” Castagna said in a company statement cited by HealthDay.
Castagna said Afrezza can be taken at the time food is eaten and may help with meals or snacks that are not planned ahead. “Afrezza allows dosing at the moment of eating, without the need for premeal planning, making it a practical option for unplanned meals and snacks on the go,” he said.
HealthDay reported that Afrezza is meant to mimic the body’s mealtime insulin response. The product’s inhaled delivery route differs from the injections commonly used by people who need rapid-acting insulin around meals.
The approval applies to children and adolescents with either type 1 or type 2 diabetes who are at least 6 years old, according to HealthDay. The report did not include additional prescribing limits, pricing information or launch timing for the expanded pediatric indication.
Afrezza’s broader clearance puts MannKind’s inhaled insulin product into a pediatric diabetes market where daily treatment often requires repeated dosing decisions around food, activity and blood glucose levels. HealthDay reported that the newly approved use is tied specifically to mealtime insulin delivery through the company’s Technosphere platform.
This story draws on original reporting from Medical Xpress.