AstraZeneca (AZ) has secured China approval for Fasenra (benralizumab) to treat severe eosinophilic asthma in children aged 6 to 12, based on Phase III TATE trial data showing consistent pharmacokinetics and safety with adult studies. The anti-IL-5Rα mAb demonstrated efficacy via subcutaneous dosing every 4 weeks for the first three doses followed by 8-week maintenance. Fasenra, first approved in the US in 2017, now addresses China's 14.6% childhood asthma prevalence where severe cases account for 6.7% of paediatric patients with high hospital readmission rates.

The drug has global approvals for severe asthma and eosinophilic granulomatosis with polyangiitis, treating over 150,000 patients worldwide. This paediatric indication expansion provides a maintenance therapy option for uncontrolled cases that risk developmental impacts and life-threatening exacerbations.

According to PharmCube's NextBiopharm® database, the medicine is being developed in 13 other indications. Click here to request a free trial for NextBiopharm®.