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.
“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.”
Reference
1. Fasenra approved for treatment of children aged 6 to 11 with severe asthma. AstraZeneca. 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. 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
Bimekizumab Shows Sustained Efficacy in Treating Axial Spondyloarthritis for 52 Weeks
April 30th 2024Results from a study presented at the Academy of Managed Care Pharmacy 2024 annual meeting demonstrated sustained efficacy of bimekizumab compared with placebo in patients with non-radiographic and radiographic axial spondyloarthritis (axSpA) at week 52.
Read More
USPSTF Lowers Age for Biennial Mammograms to 40, Citing Early Detection Benefit
April 30th 2024The USPSTF lowered the recommended starting age for mammograms from 50 to 40 years, citing moderate benefits for early detection in this age group. Disparities persist, especially for Black women, highlighting the need for improved access to health care and social support.
Read More
Tisotumab Vedotin Gains Full FDA Approval for Recurrent or Metastatic Cervical Cancer
April 30th 2024The FDA granted full approval for tisotumab vedotin-tftv to treat recurrent or metastatic cervical cancer that progressed after chemotherapy, offering patients improved overall survival and a manageable safety profile.
Read More