Breakthrough T1D, the leading global type 1 diabetes (T1D) research and advocacy organization, applauds today’s decision by the U.S. Food and Drug Administration (FDA) approving Afrezza for use in children and adolescents ages 6-17 with T1D.
Afrezza, first approved by the FDA in 2014 for use in adults with diabetes, is a rapid-acting, inhaled mealtime insulin taken at the start of a meal. Today’s approval extends access to the pediatric T1D population for the first time, making Afrezza the first and only inhaled mealtime insulin approved for use in children and adolescents with T1D.
“The FDA’s approval of inhaled insulin for children and adolescents with type 1 diabetes represents an exciting advancement in the field, not because it replaces what we already have, but because it gives us another meaningful option to offer our children, adolescents, and their families. For children who struggle with pre-meal insulin dosing, or who are unable or uninterested in using automated insulin delivery systems, having a rapid-acting mealtime insulin they can inhale rather than inject could make a real difference in their daily lives,” said Brynn Marks, MD, Senior Director of Medical Affairs at Breakthrough T1D. “Diabetes care is never one-size-fits-all, and this approval provides another much-needed treatment option in the toolkit.”
The pediatric approval was supported by the INHALE-1 clinical trial, which evaluated the safety and efficacy of Afrezza as a mealtime insulin in children and adolescents with T1D. MannKind Corporation is continuing to study Afrezza in this population to gather additional long-term data on its use in children and adolescents.
Breakthrough T1D has long advocated for expanding the range of treatment options available to children and adolescents with T1D. We thank the FDA for recognizing the unmet need in pediatric T1D care, and we are grateful to MannKind Corporation for their continued research and commitment to expanding options for children and adolescents living with T1D.
