AstraZeneca's Fasenra® Gains New China Approval for Severe Eosinophilic Asthma in Children Aged 6 to <12

This approval is based on the positive results of the global multicenter, open-label TATE Phase III clinical trial. This isIs an open-label Phase III clinical trial conducted in the United States and Japan, aiming to evaluate the pharmacokinetics of Benralizumab in SEA pediatric patients aged 6-11.（PK）, Pharmacodynamics（PD）And long-term safety.

In the clinical trial,Benralizumab is administered via subcutaneous injection, once every 4 weeks for the first three doses, then once every 8 weeks thereafter. The results showed,The trialReached the primary endpoint, which has shown good pharmacokinetics, efficacy, and safety in SEA children aged 6-11, consistent with results from adolescent and adult studies, supporting its use in the pediatric population.

Benralizumab is a biologic agent that precisely targets eosinophils and acts as an anti-IL-5R.Previously approved by the NMPA for the first time in August 2024 forMaintenance Treatment of SEA in Adults and Adolescents Aged 12 Years and AboveIn the United States, Benralizumab has been approved for 3 indications:

• Add-on maintenance treatment for severe eosinophilic asthma patients aged 12 years and above(November 2017)；

• Add-on maintenance treatment for severe asthma patients aged 6 to 11 with eosinophilic phenotype(April 2024)；

• For Adult Eosinophilic Granulomatosis with Polyangiitis(September 2024)。

Since its initial approval, the sales of Benralizumab have maintained steady growth, entering 2021.$10 billionRow, global sales reached in 2024$16.89 billion, an increase of 8.76% over the same period last year. According to the disclosure in 25 years,Semi-Annual ReportShow that the drug's sales reached$920 million, a year-on-year increase of 18%.

Screenshot source: Insight database