What the FDA approval of benralizumab means for children with severe asthma

The FDA has approved AstraZeneca's benralizumab (Fasenra) as an add-on maintenance therapy for patients aged 6 to 11 years with severe asthma, offering another treatment option to the patient population to reduce disease burden.¹

The approval for asthma patients with an eosinophilic phenotype is based on the open-label, non-randomized, multinational, parallel assignment TATE study (NCT04305405).

Click here for more FDA approval data.

In this Contemporary Pediatrics video interview, Juanita Mora, MD, allergist, immunologist, Chicago, Illinois; national medical spokesperson, American Lung Association, explains the benefits of the FDA's decision, that will improve quality of life in severe asthma pediatric patients.

"[I'm] really super excited to have another option these severe asthmatics," Mora said. "When we're talking about severe asthma, it could be up to a million children who are inflicted. They're missing a lot of days of school, they're missing a lot of activities, can't play sports, and they often suffer a lot of as well."

The monoclonal antibody binds to IL-5 receptor alpha directly on eosinophils and then leads to swift blood and tissue eosinophil depletion.¹

"By blocking IL-5, we basically block this cell from causing inflammation in the lungs," added Mora. "What's been proven in studies is that it helps children and adults who are on this medication to be able to have less days of hospitalization, less albuterol use, less emergency department visits, and an improved quality of life which is exactly what we want."

When assessing which patients should receive benralizumab, Mora said children who have year-round asthma symptoms and who have had 2 or more corticosteroid bursts within 12 months are prime candidates.

"If they've had prednisone twice a year, [that] is someone you should think about [treating with benralizumab]," Mora said. "The other child is that oral steroid-dependent child as well. That child that we cannot wean off the oral steroid. The third one is the child who is maximized on medications, the inhaled corticosteroids and long acting albuterol medication... They're already on leukotriene inhibitors and they're still struggling with their asthma."

References:

1. Smith, T. FDA approves benralizumab for children aged 6 to 11 years with severe asthma. Contemporary Pediatrics. April 11, 2024. Accessed April 11, 2024. https://www.contemporarypediatrics.com/view/fda-approves-benralizumab-for-children-6-to-11-years-with-severe-asthma

2. PK/​PD and Long Term Safety Study of Benralizumab in Children With Severe Eosinophilic Asthma (TATE). ClinicalTrials.gov. Updated May 18, 2023. Accessed April 11, 2024. https://clinicaltrials.gov/study/NCT04305405