AstraZeneca’s Tezspire (tezepelumab) has been approved in Japan for the treatment of bronchial asthma in patients with severe or refractory disease in whom asthma symptoms cannot be controlled with mid- or high-dose inhaled corticosteroids and other long-term maintenance therapies.
The approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) was based on efficacy and safety results from the PATHFINDER clinical trial programme. The application included results from the pivotal NAVIGATOR Phase III trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.
Tezspire is the first and only biologic for severe asthma that acts at the top of the inflammatory cascade by blocking thymic stromal lymphopoietin (TSLP), an epithelial cytokine. Tezspire consistently and significantly reduced asthma exacerbations across the PATHWAY Phase II and NAVIGATOR Phase III clinical trials which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide (FeNO).
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.”
In clinical studies, the most common adverse reactions in patients who received Tezspire were pharyngitis, arthralgia, rash and injection site reactions. 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.
