AstraZeneca's IL-5Rα Monoclonal Antibody Fasenra Receives FDA Approval for Expanded Use in Children Aged 6–11 with Severe Eosinophilic Asthma

Apr 12, 2024 09:08 CST Updated 09:08

AstraZeneca

Biopharmaceutical Manufacturer

On April 11, AstraZenecaIL-5Rα Monoclonal AntibodyFasenra (benralizumab) Receives FDA Approval for Expanded Use in the U.S. as Add-On Maintenance Treatment for Severe Asthma with Eosinophilic Phenotype in Patients Aged 6 to 11.

Benralizumab was initially developed by Kyowa Kirin. In December 2006, MedImmune reached an agreement with Kyowa Kirin to obtain the commercialization rights of benralizumab in the United States, Europe, and other countries. In April 2007, AstraZeneca acquired MedImmune for $15.6 billion, bringing 45 pipeline products under its umbrella. In October 2016, AstraZeneca expanded the commercialization rights of benralizumab to Japan. In March 2019, AstraZeneca entered into a new licensing agreement with Kyowa Kirin to obtain the development and commercialization rights of benralizumab in Asia as well as global commercialization rights.

Benralizumab can directly bind to the IL-5 receptor α on eosinophils and attract natural killer cells to induce rapid and nearly complete depletion of eosinophils through apoptosis (programmed cell death). In November 2017, benralizumab was approved for the first time in the United States and marketed under the brand name Fasenra for add-on maintenance treatment of severe eosinophilic asthma in patients aged 12 years and older.

This approval to expand the eligible population was supported by evidence from an open-label, multi-national, non-randomized, parallel-group Phase III TATE trial, as well as adequately controlled trials conducted in adult and adolescent populations. In the TATE study, Fasenra met the primary endpoint, with pharmacokinetics (PK) and pharmacodynamics (PD) in children aged 6 to 11 with SEA consistent with previous trials.FasenraThe safety and tolerability were consistent with the known profile of this drug. For patients aged 6 years and above, weighing ≥35 kg,Fasenra'sThe recommended dose is 30mg. For patients aged 6 to 11 years weighing less than 35kg, a new 10mg dose will be provided.FaSenra is administered subcutaneously once every 4 weeks for the first 3 doses, then once every 8 weeks thereafter.

Asthma is the most common chronic disease in children, causing serious symptoms such as coughing, wheezing, and shortness of breath. Children with severe asthma and their families face a heavy burden, including impaired academic performance, significantly increased use of healthcare resources, and reduced quality of life. Severe asthma is a debilitating type of asthma that is more complex to treat and presents significant challenges.

Liz Bodin, Vice President of AstraZeneca US Respiratory and Immunology, said: "We are proudFasenraSo far, it has helped more than 100,000 patients in the United States.FaSenra will"Providing more options for children whose quality of life is severely affected by eosinophilic asthma is an exciting step toward revolutionizing asthma treatment."

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