FDA Approves Mepolizumab for Pediatric Severe Eosinophilic Asthma

The US Food and Drug Administration (FDA) has approved mepolizumab (Nucala) as the first biologic indicated for children aged 6-11 years old with severe eosinophilic asthma.

The approval is supported by data from an open-label trial investigating the pharmacokinetics, pharmacodynamics, and long-term safety of the interleukin 5 (IL-5)-targeting monoclonal antibody in the pediatric population.

Trial evidence from adequate and well-controlled studies featuring adult and adolescent patients also supported the pediatric indication. A 52-week phase of the study showed that the safety profile in pediatric patients aged 6-11 years was similar to the known safety profile in patients aged 12 years and older.

The 40 mg subcutaneous injection therapy was previously approved as an add-on maintenance drug for patients with severe eosinophilic asthma aged 12 years and older. Its emphasis on the prevention of eosinophil-binding has been shown to reduce eosinophil counts in patients without completing depleting them.

To date, it has been assessed in 3000-plus patients with various eosinophilic indications across 21 clinical trials.

Tonya Winders, chief executive officer and president of the Allergy and Asthma Network, shared perspective on the indication’s significance as a mother of a pediatric asthma patient.

“I know first-hand the huge impact it has on a family, from the constant worry about your child being hospitalized, to practical issues like arranging time off work to care for them,” she said in a statement. “Having Nucala approved as the first biologic for treating severe eosinophilic asthma in this young age group represents a significant step forward for the asthma community.”

Daniel Jackson, MD, of the Department of Pediatrics at University of Wisconsin, added that severe eosinophilic asthma presents as a complicated, difficult-to-treat condition. Mepolizumab has already made a difference among adolescent and adult patients.

“This approval is an important development, giving physicians like me a much-needed option to consider for our pediatric patients,” he said.