AstraZeneca’s Fasenra (benralizumab) has been approved by China’s National Medical Products Association (NMPA) for the treatment of severe eosinophilic asthma in patients aged 12 and older. The approval follows the MIRACLE Phase III trial, which demonstrated a significant reduction in asthma exacerbations and improved symptom control.
AstraZeneca’s Fasenra (benralizumab) has received approval from China’s National Medical Products Association (NMPA) for the maintenance treatment of severe eosinophilic asthma (SEA) in patients aged 12 years and older. The decision is based on the positive outcomes from the MIRACLE Phase III trial, which showed a 74% reduction in the annualized asthma exacerbation rate (AAER) when Fasenra was added to the standard of care.
The MIRACLE trial, conducted in China, South Korea, and the Philippines, involved 695 patients and demonstrated that Fasenra met all primary and key secondary endpoints. The trial not only showed a significant reduction in exacerbations but also improvements in lung function and overall asthma symptom control, providing a robust case for its approval.
Dr. Nanshan Zhong, a leading investigator in the MIRACLE trial, stated, “The recent MIRACLE trial showed that benralizumab, with its unique mechanism of action, can help patients achieve early and sustained control of their asthma symptoms. This approval gives many more patients in China the potential to benefit from this treatment.”
Severe eosinophilic asthma is a debilitating condition affecting approximately 3 million people in China. Despite its prevalence, treatment options remain limited, often resulting in misdiagnosis and undertreatment. Patients with severe asthma face frequent exacerbations, diminished lung function, and reduced quality of life, which significantly impacts their overall well-being.
With Fasenra now approved, Chinese patients with severe eosinophilic asthma have a new, effective treatment option that could lead to fewer exacerbations and better control of their symptoms. This approval is expected to ease the burden on both patients and healthcare systems by reducing asthma-related hospitalizations and healthcare costs.
While Fasenra’s approval is a significant advancement, it is essential to consider that treatment accessibility and affordability may pose challenges for widespread adoption, particularly in rural areas where healthcare resources are limited.
Ruud Dobber, Executive Vice President of AstraZeneca’s BioPharmaceuticals Business Unit, emphasized, “Today’s approval is an important step forward for the millions of patients in China living with severe asthma, offering them a new treatment option that can bring meaningful relief.”
The approval of Fasenra in China marks a critical milestone in the treatment of severe eosinophilic asthma, providing hope for improved patient outcomes. As the healthcare landscape continues to evolve, this decision could pave the way for further advancements in respiratory care.
