Fasenra (benralizumab) approved in China for the treatment of severe eosinophilic asthma – AstraZeneca

AstraZeneca’s Fasenra (benralizumab) has been approved in China by the country’s National Medical Products Association (NMPA) for the maintenance treatment of patients 12 years of age and older with severe eosinophilic asthma (SEA).

The approval is based on results from the MIRACLE Phase III trial, which was conducted in China, South Korea and the Philippines. In the trial, Fasenra achieved a statistically significant and clinically meaningful 74% reduction (0.49 in the Fasenra group compared to 1.88 in the placebo group, rate ratio 0.26, p<0.0001) in the annualised asthma exacerbation rate (AAER) when added to standard of care in patients with SEA. Fasenra met all primary and key secondary endpoints in the trial, demonstrating improvements in lung function and asthma symptom control.

It is estimated that approximately 3 million people in China have SEA. Despite the significant prevalence in China, treatment options are limited, and severe asthma is often misdiagnosed and undertreated. The burden of SEA for patients is significant with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced quality of life. Patients with severe asthma are at an increased risk of mortality and compared to patients with persistent asthma, have twice the risk of asthma-related hospitalisations. There is also a significant socio-economic burden, with these patients accounting for approximately 50% of asthma-related costs.

Dr. Nanshan Zhong, Academician of the Chinese Academy of Engineering, and International Coordinating Investigator of the trial said: “Many patients in China with severe eosinophilic asthma have uncontrolled disease and experience frequent exacerbations, symptom worsening and reduced lung function despite the use of inhaled therapies. There are several ongoing studies to address these unmet needs in China. The recent MIRACLE trial showed that benralizumab, which has a unique mechanism of action, can help patients achieve early and sustained control of their asthma symptoms. There’s now potential for many more patients in China to benefit from treatment.”

See-Lai K, et al. “Benralizumab efficacy and safety in severe asthma: a randomized trial in Asia.” Respir Med. 2024.