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 (SEA) 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 adequate and well-controlled trials in adult and adolescent populations.

In the TATE study, FASENRA met the primary endpoints, demonstrating pharmacokinetics (PK) and pharmacodynamics (PD) in children aged 6 to 11 years old with SEA 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 4 weeks for the first 3 doses, and then every 8 weeks. Asthma is the most common chronic childhood disease and can cause serious symptoms such as coughing, wheezing and difficulty breathing.

Children with severe asthma and their families face a significant burden, including impaired school performance, substantially higher healthcare resource use and a poorer quality of life. Severe asthma is a debilitating type of asthma that can be complicated and challenging to treat. FASENRA is currently approved as an add-on maintenance treatment for patients aged 6 and older with SEA in the US.

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). FASENRA (benralizumab) is currently approved in more than 80 countries, including the US, EU, and Japan, and is approved for self-administration in the US, EU and other countries. FASENRA has been prescribed to over 100,000 patients in the US.

FASENRA is in development for other diseases including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome. FASENRA was developed by AstraZeneca and is in-licensed from BioWa Inc., a wholly-owned subsidiary of Kyowa Kirin Co. Ltd., Japan.