AstraZeneca’s Fasenra (Benralizumab) was approved in China for treating severe eosinophilic asthma (SEA), offering hope to millions of patients seeking relief.

The National Medical Products Association (NMPA) of the country has approved the use of the medication to treat patients over 12 years old with SEA.

NMPA approved the treatment based on the results of the MIRACLE Phase III trial, a randomised, double-blind, parallel-group, placebo-controlled study. The trial demonstrated a significant and clinically meaningful reduction in asthma exacerbations and an improvement in asthma symptom control.

What is severe eosinophilic asthma (SEA)? 

Asthma is a significant chronic respiratory condition affecting millions of people globally. A portion (est. 10%) of these individuals experience severe asthma, which remains uncontrolled despite treatment.

Eosinophilic inflammation plays a key role in the majority of severe asthma cases. Despite using high doses of standard asthma medications, many patients continue to struggle with frequent flare-ups, reduced lung function, and a diminished quality of life.

Millions of people in China have SEA, but they are often undiagnosed and under-treated as treatment options are limited. 

Severe asthma places a heavy burden on patients, leading to frequent flare-ups and hospitalisation, reduced lung function, lower quality of life and higher risks of death as well as a higher socio-economic burden. 

What is Fasenra (Benralizumab)?

Fasenra is a biologic treatment approved in more than 80 countries, including the US, EU and Japan, to help treat SEA.

It is a monoclonal antibody that targets and reduces eosinophils, a type of white blood cell that contributes to asthma symptoms.  Fasenra is typically administered once every 8 weeks after the initial three starter doses.

Study Results

Fasenra achieved a statistically significant and clinically meaningful 74% AAER ( annualised asthma exacerbation rate) reduction over 48 weeks compared to placebo. The trial demonstrated improvements in lung function and asthma symptom control.

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Fasenra's introduction in China brings highlights millions of patients who have had limited treatment options and underscores the growing recognition of the need for targeted therapies in Eosinophilic-Associated Diseases.

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Benralizumab's Efficacy in Reducing Eosinophil Count in EoE. Messina Phase 3 Trial