Pediatric patients aged 6-11 with severe eosinophilic asthma can now receive Fasenra (benralizumab) as an add-on maintenance therapy.


RT’s Three Key Facts: 

  1. Fasenra, a monoclonal antibody treatment for severe eosinophilic asthma, was previously approved for patients aged 12 and older. It has now gained FDA approval for an expanded indication to treat children aged 6 to 11. This approval is for its use as an add-on maintenance therapy for those with an eosinophilic phenotype.
  2. The approval for the pediatric use of Fasenra was supported by results from the TATE study, an open-label, multinational, non-randomized, phase III trial. The study demonstrated that the pharmacokinetics and pharmacodynamics in children aged 6 to 11 with severe eosinophilic asthma were consistent with those observed in prior trials involving older age groups. The safety and tolerability profile of Fasenra in this trial also aligned with its known effects in previous studies.
  3. For children 6 years and older who weigh 35 kg or more, the recommended dose of Fasenra is 30 mg. A new 10 mg dose will be available for children aged 6 to 11 who weigh less than 35 kg. Fasenra is administered via subcutaneous injection; initially, it is given every four weeks for the first three doses and subsequently every eight weeks.

AstraZeneca’s Fasenra (benralizumab) is now approved by the US Food and Drug Administration (FDA) for add-on maintenance treatment for patients with severe asthma aged 6 to 11 with an eosinophilic phenotype.

Fasenra was first approved in 2017 as an add-on maintenance for the treatment of severe eosinophilic asthma in patients aged 12 and older.

This additional indication for Fasenra was supported by evidence from TATE, an open-label, multinational, non-randomized, parallel assignment phase III trial, as well as trials in adult and adolescent populations.

Trial Results: Safety and Efficacy

In the TATE study, Fasenra met the primary endpoints, demonstrating pharmacokinetics and pharmacodynamics in children aged 6 to 11 years old with severe eosinophilic asthma were consistent with those seen in prior trials. The safety and tolerability of Fasenra in the trial was also consistent with the known profile of the medicine. 

The recommended dose for Fasenra is 30 mg for patients 6 years and older who weigh 35 kg or more. For patients aged 6 to 11 who weigh less than 35 kg, a new 10 mg dose will be available. Fasenra is administered by subcutaneous injection every four weeks for the first three doses, and then every eight weeks.

“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,” says Lynda Mitchell, MA, CAE, CEO of the Allergy & Asthma Network, in a release. 

Mechanism and Global Impact

Fasenra is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of blood and tissue eosinophils in most patients via apoptosis (programmed cell death).

It is currently approved in more than 80 countries, including the United States, European Union, and Japan, and is approved for self-administration in the United States, European Union, and other countries. Fasenra has been prescribed to over 100,000 patients in the United States.

“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,” says Liz Bodin, vice president of US Respiratory & Immunology at AstraZeneca, in a release. 

Fasenra is in development for other diseases including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, and hypereosinophilic syndrome.

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