MannKind announced that it received FDA approval for its Afrezza inhaled insulin powder for children.
FDA approval covers use in children and adolescents aged 6 and older with type 1 and type 2 diabetes.
Afrezza (insulin human) inhalation powder is a fast-acting insulin formulation delivered through an inhaler device. MannKind engineered the mechanical inhaler device to slowly bring powder into the lung. A small compartment opens for the insertion of the insulin cartridge, then the user closes it. The only other component is a mouthpiece for the sake of cleanliness. Then, the inhalation takes just two seconds. It requires no electronics or extra components.
Related: Neurovalens earns FDA nod for neuromod for PTSD
MannKind says its proprietary Technosphere drug delivery platform enables the rapid absorption of insulin into systemic circulation. The ultra-rapid-acting inhaled insulin taken when eating more closely mimics the body’s natural insulin response at mealtime.
Approval expands Afrezza’s availability beyond adults, bringing a new mealtime insulin option to pediatric patients and caregivers. It follows FDA approval earlier this year for an update that revises recommendations for the starting mealtime dosage when patients switch from subcutaneous mealtime insulin regimens. The FDA also accepted a supplemental biologics license last fall for the inhaled insulin in children.
MannKind also completed enrollment in February for a study evaluating the initiation of Afrezza therapy shortly after type 1 diabetes diagnosis in pediatric patients.
The company said it made Afrezza available for eligible patients for $35 or less per month.
Michael Castagna, CEO of MannKind, said:
“For more than a century, insulin therapy for children living with diabetes has largely meant multiple daily injections. Children and their families deserve new treatment options that fit the realities of daily life. Afrezza allows dosing at the moment of eating, without the need for pre-meal planning, making it a practical option for unplanned meals and snacks on the go. Our founder, Al Mann, would be proud of the dedication and teamwork that made it possible to bring this novel innovation to children and families.”
Desmond Schatz, professor of pediatrics at the University of Florida College of Medicine, said:
“Mealtime insulin can be especially challenging for children because eating and snacking patterns, activity levels, and daily settings like school and sports often vary. 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.”
