The Food and Drug Administration (FDA) has approved Fasenra (benralizumab) for use in children between the ages of six and 11. The AstraZeneca drug has long been effective for treating severe eosinophilic asthma in patients as young as 12.
The approval follows positive results from the Pharmacokinetics and Long-term Safety (TATE) study as well as trials in adult and adolescent populations. The new FDA approval is for a 10 mg dose for children who weigh less than 77 pounds.
“Additional treatment options for children living with severe asthma are needed to help address the unmet need in this patient population and to reduce the burden of disease for the broader asthma community,” said Donna Carstens, MD, a senior director at Fasenra, AstraZeneca. “The FDA’s decision to expand the approved use of Fasenra for the add-on maintenance treatment of patients aged six to 11 years old addresses this unmet need and represents a significant step in offering children with [severe eosinophilic asthma] a wider choice of treatment in the future.”
Fasenra, which was first approved in 2017 for children older than 12 years of age, is administered by subcutaneous injection every four weeks for the first three doses then once every eight weeks as a maintenance treatment for severe eosinophilic asthma.
The TATE study was an open-label, multinational, phase 3 trial of benralizumab in children aged six to 11 years with severe eosinophilic asthma. Study results were consistent with previous Fasenra trials in assessing maximum serum concentration, clearance, half-life and blood eosinophil count as well as safety and tolerability.
