Benralizumab Receives FDA Approval as Add-On Maintenance Therapy for Children With Severe Asthma


The approval of benralizumab (Fasenra) is supported by evidence from the phase 3 TATE study.

The FDA has approved benralizumab (Fasenra) for children aged 6 to 11 years with severe eosinophilic asthma, according to an AstraZeneca press release.1 Benralizumab was first approved in 2017 as an add-on maintenance for the treatment of asthma in patients 12 years and older.

FDA approval indication | Dzmitry -

FDA approval indication | Dzmitry -

“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,” Lynda Mitchell, MA, CAE, CEO, of the Allergy & Asthma Network, said in the statement.1

Asthma is the most common chronic childhood disease, with symptoms that include coughing, wheezing, and difficulty breathing. Additionally, asthma puts a significant burden on children and their families, and it can contribute to impaired school performance, higher health care resource use, and poorer quality of life.

Benralizumab is a monoclonal antibody that binds to the IL-5 receptor alpha on eosinophils, which attracts natural killer cells to induce rapid and near-complete depletion of blood and tissue eosinophils in most patients.

Currently, benralizumab is approved in more than 80 countries, including the US, European Union (EU), and Japan. It is also approved for self-administration in the US, EU, and other countries.

This additional indication for benralizumab was supported from evidence from the phase 3 TATE study (NCT04305405), an open-label, multinational, nonrandomized, parallel assignment trial,2 as well as well-controlled trials in adult and adolescent patients.

The TATE study included 28 children aged 6 to 11 years in the US and Japan, in addition to 2 patients aged 12 to 14 years in Japan, who were administered benralizumab over 48 weeks. The study met primary end points, with pharmacokinetics and pharmacodynamics in children aged 6 to 11 years being consistent with those seen in prior trials. Benralizumab also showed safety and tolerability in the phase 3 trial that was consistent with the known profile of the drug.

Headache and pharyngitis were the most common adverse reactions, with an incidence of 5% or less. Additionally, injection site reactions, such as pain, erythema, pruritis, and papule, occurred in 2.2% of patients who received benralizumab compared with 1.9% of patients who received placebo.

The recommended dose for benralizumab is 30 mg for patients 6 years and older who weigh 77.16 lb or more. A new 10-mg dose will also be available for patients aged 6 to 11 years who weigh less than 77.16 lb. Benralizumab is administered by subcutaneous injection every 4 weeks for the first 3 doses, and then every 8 weeks.

“We’re proud that Fasenra has helped more than 100,000 patients in the US to date,” said Liz Bodin, vice president, US Respiratory & Immunology, AstraZeneca, in the statement.1 “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.”


1. Fasenra approved for treatment of children aged 6 to 11 with severe asthma. AstraZeneca. News release. April 11, 2024. Accessed April 11, 2024.

2. Wedner HJ, Fujisawa T, Guilbert TW, et al. Benralizumab in children with severe eosinophilic asthma: pharmacokinetics and long-term safety (TATE study). Pediatr Allergy Immunol. 2024;35(3):e14092. doi:10.1111/pai.14092

Related Videos
Dr Migvis Monduy
Amy Shapiro, MD
Chesahna Kindred, MD, MBA, FAAD, board-certified dermatologist, Kindred Hair & Skin Center.
Mila Felder, MD, FACEP, emergency physician and vice president for Well-Being for All Teammates, Advocate Health
Binod Dhakal, MD
Chesahna Kindred, MD, MBA, FAAD, board-certified dermatologist, Kindred Hair & Skin Center
Mila Felder, MD, FACEP, emergency physician and vice president for Well-Being for All Teammates, Advocate Health
Binod Dhakal, MD, Medical College of Wisconsin, lead CARTITUDE-4 investigator
Shawn Tuma, JD, CIPP/US, cybersecurity and data privacy attorney, Spencer Fane LLP
Judith Alberto, MHA, RPh, BCOP, director of clinical initiatives, Community Oncology Alliance
CH LogoCenter for Biosimilars Logo