China Approves AstraZeneca’s Fasenra for Severe Eosinophilic Asthma

On August 20, 2024, AstraZeneca announced that the country’s National Medical Products Administration (NMPA) has approved its drug, Fasenra (benralizumab). This approval is for the treatment of severe eosinophilic asthma in individuals aged 12 and older. The approval is based on the MIRACLE Phase III clinical trial results, which showed significant improvements in the average annual incidence rate of asthma exacerbations and symptom control with the biologic. 

MIRACLE Trial Shows Fasenra Reduces Annual Asthma Exacerbations by 74%

The MIRACLE trial, conducted in China, South Korea, and the Philippines, included 695 patients aged 12 to 75 with uncontrolled asthma. Results showed that Fasenra reduced the annual incidence of asthma exacerbations by 74% when added to standard treatment. Specifically, the Fasenra group had an incidence rate of 0.49, compared to 1.88 in the placebo group, with a rate ratio of 0.26 (p<0.0001). The trial achieved both primary and key secondary endpoints, improving lung function and asthma symptom control. As a result, Fasenra significantly reduced asthma exacerbations and enhanced patients’ quality of life.

Additionally, within 48 weeks, Fasenra improved patients’ vital capacity in 1 second (FEV1) and total asthma symptom score (TASS). Therefore, Fasenra demonstrated a lasting effect on lung function and symptom control, highlighting its potential as an effective treatment for severe eosinophilic asthma.

Treatment Challenges in Severe Eosinophilic Asthma: Addressing Misdiagnosis, Limited Options, and Frequent Exacerbations

Severe eosinophilic asthma is a challenging, chronic respiratory disease affecting an estimated 300 million people worldwide, with 10% experiencing severe forms. This condition involves the “eosinophilic phenotype,” marked by a significant increase in eosinophils in the respiratory tract. Eosinophils, a type of white blood cell, link to allergic reactions and parasitic infections. In this asthma phenotype, increased eosinophils closely associate with airway inflammation, allergy, and symptom exacerbation. Consequently, patients may respond better to treatments targeting eosinophils, such as anti-IL-5 therapy.

Despite high doses of standard treatments, many patients struggle to control the disease effectively. As a result, they experience frequent exacerbations and significant lung function impairment. In China, approximately 3 million people have severe eosinophilic asthma. Due to limited treatment options, the disease often gets misdiagnosed and undertreated. This leads to frequent exacerbations, reduced lung function, and a diminished quality of life. Additionally, patients with severe asthma face an increased risk of death and twice the rate of asthma-related hospitalizations compared to those with persistent asthma.

Fasenra’s Global Availability and Expanding Indications

AstraZeneca and BioWa, Inc., a subsidiary of Japan’s Kyowa Kirin Co., Ltd., jointly developed Fasenra, which is now available in 80 countries. Several countries, including the United States, Japan, the European Union, and China, have approved it for treating severe eosinophilic asthma. To date, over 130,000 patients worldwide have received Fasenra.

Additionally, researchers are investigating Fasenra for other potential indications, including Chronic Obstructive Pulmonary Disease (COPD) and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). They are also studying it for Eosinophilic Granulomatosis with Polyangiitis (EGPA) and Hypereosinophilic Syndrome.

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Author

Bernice Lottering