HQ Team
August 20, 2024: China’s drug regulator, the National Medical Products Association, has approved AstraZeneca Plc’s asthma drug.
The NMPA approved the drug, Fasenra (benralizumab), for the treatment of severe eosinophilic asthma in patients 12 years of age and above, according to a statement from the British-Swedish drug company.
The nod was based on results from end-stage clinical trials conducted in China, South Korea and the Philippines which showed a 74% reduction in the asthma exacerbation rate in combination with standard care of quick-relief inhalers.
The results achieved improvements in lung function and asthma symptom control, according to the statement.
‘Frequent exacerbations’
“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,” said Dr Nanshan Zhong, Academician of the Chinese Academy of Engineering.
“There are several ongoing studies to address these unmet needs in China. The recent…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,” Dr Zhong, International Coordinating Investigator of the trial, said.
About three million people in China have severe eosinophilic asthma and treatment options are limited, often misdiagnosed, and undertreated.
Limited lung function
The burden of severe eosinophilic asthma 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.
Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in more than 80 countries, including the US, Japan, and the EU.
It is also approved in children and adolescents ages six and above in the US and Japan.
300 million asthmatics
Asthma is a major chronic respiratory disease that affects an estimated 300 million people worldwide.
Up to 10% of people with asthma have severe uncontrolled asthma.
Eosinophilic inflammation drives the eosinophilic phenotype of asthma, which is seen in more than 80% of patients with severe asthma, according to the statement.
