Biopharmaceutical company AstraZeneca has received approval from China's National Medical Products Association (NMPA) for the use of Fasenra (benralizumab) in patients with severe eosinophilic asthma.
The therapeutic is approved for use in those older than 12 years of age, and is based off the results of the Phase III MIRACLE trial conducted in China, South Korea and the Philippines.
During the clinical study, Fasenra exhibited a 74% reduction in the annualised asthma exacerbation rate when combined with standard of care in patients with the condition.
It also exhibited improvements in both lung function and asthma symptom control.
Although approximately 3 million people in china have SEA, treatment options for the disease are limited. Therefore, the Chinese patient population will significantly benefit from the availability of a novel maintenance treatment to improve their daily quality of life.
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.”
Executive Vice President of the BioPharmaceuticals Business Unit at AstraZeneca, Ruud Dobber, said: “Today's approval is an important step forward in the treatment of severe asthma in China, which affects millions of patients. Those living with severe asthma will soon have access to Fasenra, which rapidly targets eosinophils, resulting in a significant reduction of asthma exacerbations and clinically meaningful symptom relief for patients.”
The safety and tolerability profile for benralizumab in the MIRACLE trial was consistent with the known safety profile of the medicine.
Fasenra is currently approved as an add-on maintenance treatment for SEA in more than 80 countries, including the US, Japan, EU and now China.15-18 It is also approved in children and adolescents ages 6 and above in the US and Japan.