FDA: Fasenra Approved As Add-On Maintenance Therapy for Severe Pediatric Asthma


Fasenra was initially approved in 2017 as an add on maintenance therapy in patients aged 12 years and older.

The FDA has approved benralizumab (Fasenra) as an add-on maintenance treatment for pediatric patients aged 6 to 11 years with severe asthma, with an eosinophilic phenotype. The medication, manufactured by AstraZeneca, first received approval in 2017 as an add-on maintenance therapy for severe eosinophilic asthma in patients aged 12 years and older.1

The agency evaluated evidence from the TATE study (NCT04305405), a multinational, open-label, non-randomized, parallel assignment, phase 3 clinical trial. Data from TATE were published earlier this year in the journal Pediatric Allergy and Immunology.2

eosinophils in the bloodstream | freshidea - stock.adobe.com

eosinophils in the bloodstream | freshidea - stock.adobe.com

Researchers for the TATE study evaluated the pharmacokinetics (PK), pharmacodynamics (PD), and safety of benralizumab, an anti-interleukin-5 receptor a monoclonal antibody, in a total of 28 pediatric study participants. After screening, patients were divided into dosing groups by weight: 15 were assigned to the lower dose/weight group (10 mg/<35 kg) and 13 were assigned to the higher dose/weight group (30 mg/≥35 kg). Patients were primarily boys, with a mean age of 8.8±1.9 years across both dosing groups.

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Benralizumab met the primary study endpoints, “demonstrating PK and PD in children aged 6 to 11 years with [severe eosinophilic asthma that] were consistent with those seen in prior trials.”1 Mean Cmax was 1901.2 and 3118.7 ng/mL in the lower and higher dosing groups, respectively; clearance was 0.257, and mean t1/2 was 14.5 days. Investigators also noted a “near-complete depletion of blood eosinophils” across dose/weight groups.1,2

Results of additional exploratory analyses found improvements in forced expiratory volume in 1 second (FEV1), mean Asthma Control Questionnaire-Interviewer Administered score, patient/clinician global impression of change score, and exacerbation rates throughout the duration of the study.2 Safety and tolerability was consistent with previous research data and the known profile of the medication.2

“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 of the Allergy and Asthma Network.1

Asthma frequently begins in childhood, usually before the age of 5. It is the most common chronic disease in pediatric patients, and can lead to a number of adverse outcomes, both clinical and social.3 According to the Asthma and Allergy Foundation of America, there are approximately 4.5 million children under the age of 18 living with asthma in the United States.4

The most common adverse reactions to benralizumab treatment are headache and pharyngitis. The drug is not indicated for the treatment of other eosinophilic conditions, nor is it indicated to relieve acute bronchospasm or status asthmaticus.

READ MORE: Respiratory Resource Center

1. Fasenra approved for treatment of children aged 6 to 11 with severe asthma. News release. AstraZeneca. April 11, 2024. Accessed April 12, 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. Wedner HJ, Fujisawa T, Guilbert TW, for the TATE Investigators. Benralizumab in children with severe eosinophilic asthma: Pharmacokinetics and long-term safety (TATE study). Pediatr Allergy Immunol. 2024;35(3):e14092. doi:10.1001/pai.14092
3. Asthma in children. Medline Plus. Accessed April 12, 2024. https://medlineplus.gov/asthmainchildren.html
4. Asthma facts and figures. Asthma and Allergy Foundation of America. Updated September 2023. Accessed April 12, 2024. https://aafa.org/asthma/asthma-facts/
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