BEIJING—The National Medical Products Administration (NMPA) of China has granted market approval for AstraZeneca (NASDAQ: AZN, LON: AZN) ‘s Fasenra (benralizumab) as a maintenance therapy for severe eosinophilic asthma (SEA) in adults and adolescents aged 12 and above. This decision follows the positive outcomes of the MIRACLE Phase III clinical trial, conducted across China, South Korea, and the Philippines, reinforcing the drug’s efficacy and safety profile.
Fasenra, a monoclonal antibody that selectively targets the IL-5 receptor, has demonstrated its ability to rapidly reduce eosinophil levels in asthmatic patients. Initially approved in the US in November 2017 for patients aged 12 and above with SEA, Fasenra has since received marketing authorizations in Japan, the European Union (EU), and other regions. In April 2024, the US and Japan expanded the drug’s approval to include patients aged 6 and above, marking a significant step in broadening access to treatment.
The China approval is a testament to the drug’s performance in the MIRACLE trial, where benralizumab showed a 74% reduction in the annual acute attack rate (AAER) compared to placebo, meeting all primary and key secondary endpoints. The treatment also led to improvements in lung function and asthma symptoms, offering a promising therapeutic option for patients with SEA in China.- Flcube.com
