FDA Approves Benralizumab to Treat Pediatric Patients Aged 6 to 11 Years With Severe Asthma


Benralizumab was previously approved by the FDA in 2017 as an add-on maintenance therapy for patients 12 years and older.

The FDA has approved benralizumab (Fasenra; AstraZeneca) as an add-on therapy when treating patients aged 6 to 11 years that have severe asthma with an eosinophilic phenotype. This second indication comes after the phase 3 TATE trial (NCT04305405), which demonstrated positive results.1

Asthma treatments -- Image credit: Olga Miltsova | stock.adobe.com

Image credit: Olga Miltsova | stock.adobe.com

Benralizumab is a monoclonal antibody which binds directly to IL-5 receptor alpha on eosinophils, attracting natural killer cells that induce rapid and near-complete depletion of blood and tissue eosinophils in most patients through programmed cell death. Currently, the treatment is also in development for other diseases such as chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, and hypereosinophilic syndrome. It was initially approved by the FDA in 2017 for add-on maintenance treatment of patients who are 12 years of age and older with severe eosinophilic asthma (SEA).1

“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, MA, CAE, CEO, Allergy & Asthma Network, in a press release.1

The TATE trial is an open-label, multinational, non-randomized, parallel assignment phase 3 trial that evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of benralizumab in 28 pediatric patients aged 6 to 11 years, as well as 2 patients aged 12 to 14 years with SEA. Benralizumab was administered subcutaneously for every 4 weeks for the first 3 doses, then every 8 weeks (injections given during weeks 4, 8, 16, 24, 32, and 40), and patients were observed over a 48-week duration.1

About the Trial

Trial Name: PK/​PD and Long Term Safety Study of Benralizumab in Children With Severe Eosinophilic Asthma (TATE)

ClinicalTrials.gov ID: NCT04305405

Sponsor: AstraZeneca

Completion Date: September 12, 2022

The results indicate that benralizumab met its primary endpoints and demonstrated both PD and PK in the enrolled patients. Further, the study indicated similar safety and tolerability profiles that were consistent with the known profiles of the treatment. Currently, the recommended dose is 340 mg for patients who are 6 years of age and older who weight 35 kg or more, and a new 10 mg dose is available for patients aged 6 to 11 years with SEA who weigh less than the recommendation.1,2

Potential adverse effects (AEs) for benralizumab included hypersensitivity reactions (eg, anphylaxis, angioedema, rash), acute asthma symptoms or deteriorating disease, reduction of corticosteroid dosage, and parasitic infections. The most common AEs (≥5%) include headache and pharyngitis, and injection site reactions (eg, pain, erythema, pruritus, papule) occurred in approximately 2.2% of patients. Other AEs reported by study participants were infections (eg, nasopharyngitis, sinusitis, viral upper respiratory tract infection), constipation, diarrhea, musculoskeletal pain, as well as skin and subcutaneous disorders (eg, eczema, urticaria, atopic dermatitis).1,2

“We’re proud that [benralizumab] has helped more than 100,000 patients in the US to date. Expanding options for children whose quality of life has been drastically impacted by SEA with the help of [benralizumab] is an exciting step in our mission to revolutionize asthma care,” said Liz Bodin, vice president, US Respiratory & Immunology, AstraZeneca, in the press release.1

1. AstraZeneca. FASENRA approved for treatment of children aged 6 to 11 with severe asthma. News release. 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
2. PK/​PD and Long Term Safety Study of Benralizumab in Children With Severe Eosinophilic Asthma (TATE).ClinicalTrials.gov identifier: NCT04305405. Updated May 18, 2024. Accessed April 11, 2024. https://clinicaltrials.gov/study/NCT04305405
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