The China National Medical Products Association (NMPA) has approved AstraZeneca‘s Fasenra (benralizumab) as a maintenance treatment for individuals aged 12 years and older with severe eosinophilic asthma (SEA).
The endorsement follows the positive results from the MIRACLE Phase III study.
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The randomised, double-blind, placebo-controlled study was conducted across China, South Korea and the Philippines.
It aimed to assess the efficacy and safety of Fasenra in patients aged 12 to 75 years with a history of uncontrolled asthma despite receiving medium or high-dose inhaled corticosteroids plus long-acting β2-agonists, with or without oral corticosteroids and asthma controllers.
Fasenra demonstrated a 74% reduction in the annualised asthma exacerbation rate when used alongside standard care in patients with SEA.
It also met all primary and key secondary endpoints, showing improvements in lung function and asthma symptom control.
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By GlobalDataThe safety profile of the asset observed in the MIRACLE trial was in line with the previously established safety data of the medication.
Developed by AstraZeneca and in-licensed from Kyowa Kirin subsidiary BioWa, Fasenra is now approved in 80 countries.
AstraZeneca BioPharmaceuticals Business Unit executive vice-president Ruud Dobber stated: “The approval is an important step forward in the treatment of severe asthma in China, which affects millions of patients.
“Those living with severe asthma will soon have access to Fasenra, which rapidly targets eosinophils, resulting in a significant reduction of asthma exacerbations and clinically meaningful symptom relief for patients.”
The latest development comes after the company’s Imfinzi (durvalumab) plus chemotherapy secured US Food and Drug Administration approval for non-small cell lung cancer in the perioperative setting.
