By Fineline Cube 
UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) announced the official approval of a new indication for Fasenra (benralizumab injection) in China. This makes it the first respiratory biologic from AstraZeneca available in the Chinese market. The new indication is for the maintenance treatment of severe eosinophilic asthma (SEA) in children aged 6 to less than 12 years old.
Clinical Trial Basis
The approval is based on positive results from the global, multicenter, open-label Phase III TATE clinical trial. In the trial, benralizumab met its primary endpoints, demonstrating favorable pharmacokinetic, pharmacodynamic, and safety profiles in children aged 6-11 years with SEA. These results were consistent with findings from studies conducted in adolescents and adults, supporting its use in the pediatric population.
Administration Details
Benralizumab is administered via subcutaneous injection. The dosing regimen involves three initial doses given once every four weeks, followed by a maintenance dose every eight weeks.
Drug Mechanism
Benralizumab is an anti-IL-5R biologic that precisely targets eosinophils. It was previously approved in China for the maintenance treatment of SEA in adults and adolescents aged 12 years and older. This indication has also been approved in over 80 countries and regions, including the United States, the European Union, and Japan. Additionally, the SEA indication for children aged 6-11 years has been approved in the U.S. and Japan.-Fineline Info & Tech