AstraZeneca severe asthma treatment Tezspire gets Japanese nod

Hironori Sagara, Professor, and Chairman of the Department of Medicine Division of Respiratory Medicine & Allergology, Showa University School of Medicine, Tokyo, Japan, said: "Severe asthma is a debilitating disease, and many patients continue to experience frequent exacerbations and a significantly reduced quality of life despite recent advances in treatment. Across clinical trials, Tezspire has demonstrated significant results in a broad population of severe asthma patients, and with this approval, physicians can now offer patients in Japan a meaningful new treatment option."

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: "Tezspire is the first and only biologic approved by the Japanese Ministry of Health, Labour and Welfare that has been shown to consistently and significantly reduce attacks in exacerbation trials in a broad population of severe asthma patients irrespective of biomarker levels. Tezspire has the potential to improve outcomes for many patients with severe asthma, and we are working to make this important medicine available in Japan as quickly as possible."

The results from the NOZOMI Phase III long-term safety trial of Tezspire in Japanese patients were published in The Journal of Asthma in June 2022.

Results from the NAVIGATOR Phase III trial were published in The New England Journal of Medicine in May 2021.

Tezspire is approved in the US, the EU, and other countries for the treatment of severe asthma. Other regulatory reviews evaluating Tezspire are ongoing in several markets around the world.