China’s National Medical Products Association (NMPA) has approved AstraZeneca’s Fasenra (benralizumab) for the maintenance treatment of patients aged 12 and older with severe eosinophilic asthma (SEA).
The approval is based on results from the MIRACLE Phase III trial, which researchers 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.2 Fasenra met all primary and key secondary endpoints in the trial, demonstrating improvements in lung function and asthma symptom control.
Experts estimate that approximately 3 million people in China have SEA. Despite its significant prevalence in China, treatment options remain 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.
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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.”
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca 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 currently treats SEA as an add-on maintenance therapy in more than 80 countries, including the US, Japan, the EU, and now China. It also treats children and adolescents aged 6 and above in the US and Japan.
