FDA Approves AstraZeneca’s Fasenra as Add-On Maintenance Therapy for Children Aged 6 to 11 with Severe Asthma

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AstraZeneca announced that the FDA has expanded the approval of Fasenra (benralizumab) to treat severe asthma in children aged 6 to 11 years with an eosinophilic phenotype. The approval is based on results from AstraZeneca’s Phase III TATE trial and other studies showing consistent pharmacokinetics and pharmacodynamics in the young age group. Additionally, safety and tolerability matched up with previous findings. Upon availability, doses of Fasenra will be distributed at 30 mg for children weighing 77 lbs. or more. This expanded approval follows the drug’s initial approval to treat severe asthma in children over 12 years of age in 2017.¹

“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, the Allergy & Asthma Network, in a press release.

Fasenra’s 2017 approval was based on results from the WINDWARD clinical trial program, which included the Phase III SIROCCO, CALIMA, and ZONDA trials. According to the company, the eight-week benralizumab dosing regimen showed a 51% decrease in annual asthma exacerbation rate as opposed to placebo, major improvements in lung function, a 75% median reduction in daily oral corticosteroid (OCS) use, with discontinuation of OCS use in 52% of those deemed eligible, and a range of adverse events (AEs) that were similar to placebo.²

“This is an important day for severe, eosinophilic asthma patients who have had limited treatment options for far too long, with many relying on oral steroids to manage their symptoms,” said Eugene R. Bleecker, MD, professor, co-director, genetics, genomics, precision medicine, University of Arizona Health Sciences, lead investigator of the Phase III SIROCCO study, in a press release. “Fasenra has a strong clinical profile which includes the ability to show lung function improvement after the first dose, the potential to reduce – or even stop - oral steroid use, and the convenience of 8-week dosing. Fasenra also treats a distinct patient phenotype, helping physicians select the right patient in clinical practice with more confidence.”

According to the Asthma and Allergy Foundation of America, 38.7% of children aged 18 years old and younger in the United States who were suffering from asthma had one or more asthma attacks in 2021, with 63.1% under the age of 5 years experiencing at least one asthma attack. Despite this, Centers for Disease Control and Prevention data shows that pediatric asthma attacks declined between 2001 and 2020.³

“We’re proud that Fasenra 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 severe eosinophilic asthma with the help of Fasenra is an exciting step in our mission to revolutionize asthma care,” said Liz Bodin, VP, US respiratory & immunology, AstraZeneca, in the press release.

References

1. FASENRA approved for treatment of children aged 6 to 11 with severe asthma. AstraZeneca. 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. FASENRA (benralizumab) receives US FDA approval for severe eosinophilic asthma. AstraZeneca. November 14, 2017. Accessed April 11, 2024. https://www.astrazeneca-us.com/media/press-releases/2017/fasenra-benralizumab-receives-us-fda-approval-for-severe-eosinophilic-asthma-11142017.html#

3. Asthma Facts. AAFA. Accessed April 11, 2024. https://aafa.org/asthma/asthma-facts/#:~:text=What%20Are%20the%20Rates%20of,attacks%20in%20the%20past%20year.&text=About%2063.1%25%20of%20children%20under,with%20asthma%20had%20an%20attack.