AstraZeneca's Fasenra (benralizumab) has received approval from China’s National Medical Products Association (NMPA) for use in patients aged 12 and older with severe eosinophilic asthma (SEA). This approval is based on data from the MIRACLE Phase III clinical trial, which demonstrated significant benefits in reducing asthma exacerbations and improving overall asthma control.
Key Findings from the MIRACLE Trial
The MIRACLE trial was conducted across China, South Korea, and the Philippines. In this study, Fasenra, when added to standard asthma care, led to a 74% reduction in the annualized asthma exacerbation rate (AAER). Specifically, the exacerbation rate was 0.49 for patients receiving Fasenra compared to 1.88 for those on placebo, which is a statistically significant outcome. The trial also showed improvements in lung function and better management of asthma symptoms, meeting all primary and key secondary endpoints.
Prevalence and Challenges of Severe Eosinophilic Asthma in China
An estimated 3 million people in China suffer from SEA. Despite its prevalence, SEA often remains misdiagnosed and inadequately treated, leaving patients at risk for frequent exacerbations, impaired lung function, and a diminished quality of life. Patients with severe asthma face higher mortality risks and are twice as likely to require hospitalization compared to those with persistent asthma. The condition also imposes a significant economic burden, accounting for nearly half of the costs associated with asthma treatment in the country.
Understanding Severe Asthma and the Role of Fasenra
Asthma is a chronic respiratory condition affecting around 300 million people globally. About 10% of these individuals have severe asthma that remains uncontrolled despite treatment. Eosinophilic inflammation is a key driver in more than 80% of severe asthma cases, and even with high doses of standard asthma medications, patients may experience frequent flare-ups and reduced lung function, impacting their quality of life.
Details of the MIRACLE Phase III Trial
The MIRACLE study was a randomized, double-blind, placebo-controlled trial involving 695 patients aged 12 to 75 from China, South Korea, and the Philippines. Participants had a history of uncontrolled asthma and were treated with medium or high doses of inhaled corticosteroids combined with long-acting β2-agonists, with or without oral corticosteroids and additional asthma treatments.
The primary endpoint focused on reducing the AAER over 48 weeks in patients with severe eosinophilic asthma, particularly those with baseline blood eosinophil counts of 300/μL or higher. The results indicated a 74% reduction in AAER for patients treated with Fasenra compared to the placebo group.
Secondary endpoints included improvements in lung function, asthma symptom scores, and overall asthma control, as well as reductions in emergency room visits, hospitalizations, and blood eosinophil levels.
Global Reach and Ongoing Development of Fasenra
Fasenra is now approved in more than 80 countries, including the United States, European Union, Japan, and China. Over 130,000 patients worldwide have been treated with Fasenra. AstraZeneca is also exploring the use of Fasenra for other conditions, such as chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome.
Developed by AstraZeneca, Fasenra was in-licensed from BioWa, Inc., a subsidiary of Kyowa Kirin Co., Ltd. in Japan.
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