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    AZN   GB0009895292

ASTRAZENECA PLC

(AZN)
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Delayed London Stock Exchange  -  11:35 2022-11-25 am EST
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Tezspire approved in Japan for the treatment of severe asthma

09/28/2022 | 03:49am EST

* Tezspire approved for a broad population of patients with severe asthma with no phenotype or biomarker limitations.

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.1

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.2

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.2-5 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).2,3

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.1 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.

Notes

Severe asthma

Asthma is a heterogeneous disease affecting an estimated 339 million people worldwide.6 Up to 10% of asthma patients have severe asthma.7,8 Despite the use of inhaled asthma controller medicine, currently available biologic therapies and oral corticosteroids (OCS), many severe asthma patients remain uncontrolled.7-9 Due to the complexity of severe asthma, many patients have unclear or multiple drivers of inflammation and may not qualify for or respond well to a current biologic medicine.8-11

Severe, uncontrolled asthma is debilitating with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced quality of life.7,8,12 Patients with severe asthma are at an increased risk of mortality and compared to patients with persistent asthma have twice the risk of asthma-related hospitalisations.13-15 There is also a significant socio-economic burden, with these patients accounting for approximately 50% of asthma-related costs.16

Clinical trials

In addition to the Phase IIb PATHWAY trial, the PATHFINDER programme included two Phase III trials, NAVIGATOR2,17 and SOURCE.18,19 The programme also includes additional mechanistic and long-term safety trials.20,21

NAVIGATOR is a Phase III, randomised, double-blinded, placebo-controlled trial in adults (18-80 years old) and adolescents (12-17 years old) with severe, uncontrolled asthma, who were receiving standard of care (SoC). SoC was treatment with medium- or high-dose inhaled corticosteroids plus at least one additional controller medication with or without daily OCS treatment. The trial population included approximately equal proportions of patients with high (>=300 cells per microlitre) and low (

.

(C) 2022 M2 COMMUNICATIONS, source M2 PressWIRE

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Yield 2022 2,23%
Capitalization 205 B 205 B -
EV / Sales 2022 5,15x
EV / Sales 2023 4,82x
Nbr of Employees 83 100
Free-Float 96,5%
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Pam P. Cheng Executive VP-Operations & Information Technology
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