FDA Approves Mepolizumab for Pediatric Severe Eosinophilic Asthma

SEPTEMBER 12, 2019
Kevin Kunzmann
FDAThe 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.

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