AstraZeneca's Benralizumab Gains Approval for New Indication

Stock News05-29

On May 29, the NMPA official website indicated that AstraZeneca PLC (AZN.US) has received approval for a new indication of its benralizumab. This approval is for the treatment of hypereosinophilic syndrome (HES) in adult and adolescent patients aged 12 and above without a clear non-hematological secondary cause. Benralizumab is a precision-targeted anti-IL-5R innovative biologic that specifically targets eosinophils (EOS) and was originally developed by Kyowa Kirin. The newly approved indication is for hypereosinophilic syndrome (HES). In the international multicenter Phase III NATRON clinical trial, AstraZeneca evaluated the efficacy and safety of benralizumab in treating HES patients. The primary endpoint of the trial was the time to the first worsening or relapse. The complete data from this study were first presented at the 2025 American College of Allergy, Asthma & Immunology (ACAAI) annual meeting. The study results showed that, compared to placebo, benralizumab significantly delayed the time to the first HES flare, reducing the risk of flare by 65%. Additionally, the proportion of patients experiencing disease relapse or withdrawing from the trial was lower in the benralizumab treatment group (22.4% vs. 45.5%). Furthermore, the annualized relapse rate for HES was reduced by 66% compared to the placebo group, with rates of 0.41 per year and 1.23 per year, respectively.

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