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FDA Approves Benralizumab as Add-On Maintenance Therapy for Children Aged 6-11 Years with Severe Asthma


The additional indication for benralizumab was supported by data from the phase 3 TATE trial.

FDA Approves Benralizumab as Add-On Maintenance Therapy for Children Aged 6-11 Years with Severe Asthma / Image credit: ©Argus/AdobeStock


The US Food and Drug Administration approved benralizumab (Fasenra®, AstraZeneca) for add-on maintenance treatment for patients with severe asthma aged between 6 and 11 years with an eosinophilic phenotype, announced the manufacturer on April 11, 2024.

Benralizumab is a monoclonal antibody which binds directly to IL-5 receptor alpha on eosinophils, leading to swift and nearly complete blood and tissue eosinophil depletion through apoptosis among most patients, according to AstraZeneca. 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.

“We welcome additional treatment options for children living with severe asthma, a condition that remains complicated to manage, further helping to address the unmet need in this patient population and reducing the burden of disease for the broader asthma community,” said Lynda Mitchell, CEO of the Allergy & Asthma Network, in the press release.

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, according to the press release.

The recommended dosage for benralizumab is 30 mg for patients aged 6 years and older who weight 35 kg or more. Among patients aged 6-11 years who weigh less than 35 kg, a new 10 mg dose will be available, added AstraZeneca in the statement.

Benralizumab is administered by subcutaneous injection every 4 weeks for the first 3 doses, and then every 8 weeks. It is currently approved as an add-on maintenance treatment for patients aged 6 years and older with SEA in the US.

“We’re proud that FASENRA has helped more than 100,000 patients in the US to date,” stated Liz Bodin, vice president, US Respiratory & Immunology, AstraZeneca, in the release. “Expanding options for children whose quality of life has been drastically impacted by severe eosinophilic asthma with the help of FASENRA is an exciting step in our mission to revolutionize asthma care.”

Source: FASENRA approved for treatment of children aged 6 to 11 with severe asthma. News release. AstraZeneca. April 11, 2024. Accessed April 11, 2024. https://www.astrazeneca-us.com/media/press-releases/2024/fasenra-approved-for-treatment-of-children-aged-6-to-11-with-severe-asthma.html.

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