FDA Approves Benralizumab as Add-On Maintenance Therapy for Children with Severe Asthma: Daily Dose

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Last week, we reported on the US Food and Drug Administration (FDA) approval of benralizumab (Fasenra®, AstraZeneca) for add-on maintenance treatment for patients with severe asthma aged between 6 and 11 years with an eosinophilic phenotype.

The approval

Benralizumab was originally approved in 2017 as an add-on maintenance for the treatment of severe eosinophilic asthma (SEA) in patients aged 12 years and older.

The additional indication for benralizumab was supported by data from the phase 3 TATE study, an open-label, non-randomized, multinational, parallel assignment trial in children aged 6 to 11 years, as well as adequate and well-controlled trials in adults and adolescents. The TATE study examined the pharmacokinetics (PK), pharmacodynamics (PD), and safety of benralizumab administered subcutaneously in 28 children in the US and Japan aged 6-11 years, as well as 2 patients aged 12-14 years in Japan with SEA over 48 weeks.

Benralizumab met the primary endpoints of the trial, demonstrating PK, PD, and safety results in the younger population consistent with that of previous trials. The safety and also tolerability of benralizumab were consistent with the medication’s known profile.

The recommended dosage for benralizumab is 30 mg for patients aged 6 years and older who weight 35 kg or more. Benralizumab is administered by subcutaneous injection every 4 weeks for the first 3 doses, and then every 8 weeks.

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