Chinese Authority Approves Severe Eosinophilic Asthma Maintenance Treatment for Ages 12 and Up

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China’s National Medical Products Association has approved Fasenra (benralizumab), a maintenance treatment developed by AstraZeneca for severe eosinophilic asthma (SEA), for use in SEA patients in China age 12 and older (1). A press release from AstraZeneca on Aug. 20, 2024 said that China now joins a list of more than 80 countries, including the United States, Japan, and across the European Union, that have approved Fasenra as an add-on treatment for SEA. In the US and Japan, the approved age range is lowered to six years old.

“Today's approval is an important step forward in the treatment of severe asthma in China, which affects millions of patients,” Ruud Dobber, executive vice president of the biopharmaceuticals business unit of AstraZeneca, said in the press release. “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.”

Eosinophilic inflammation, or that which concerns white blood cells, drives the eosinophilic phenotype of asthma, according to AstraZeneca, and is seen in more than 80% of patients diagnosed with severe asthma (1). Although not all types of asthma can be severe, it is a chronic respiratory disease that affects more than 300 million people worldwide—up to 10% of those presenting with severe asthma that is uncontrolled.

An estimated 3 million people in China have SEA, but options for treatment are limited, and misdiagnosed or undertreated SEA can cause significant limitations to lung function, reduced quality of life, increased risk of mortality, and twice the risk of asthma-related hospitalizations as those simply with persistent asthma (1). A Phase III trial (MIRACLE) of nearly 700 patients across China, South Korea, and the Philippines showed that the use of Fasenra, when added to the standard of care for SEA patients, resulted in a 74% reduction in annualized asthma exacerbation rate, showing improvements in lung function and asthma system control.

“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,” Nanshan Zhong, MD, academician of the Chinese Academy of Engineering and International Coordinating Investigator of the trial, said in the press release. “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.”

Previously, in 2019, Fasenra had been approved by FDA in the form of a pre-filled, single-use auto-injector, called the Fasenra Pen, which allowed for the options of administration in a doctor’s office, or self-administration at home (2).

References

1. AstraZeneca. Fasenra Approved in China for the Treatment of Severe Eosinophilic Asthma. Press Release. Aug. 20, 2024.
2. Pharmaceutical Technology. FDA Approves AstraZeneca Asthma Drug in Auto-Injector Pen. PharmTech.com, Oct. 11, 2019.