The approval by the
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
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
Results from the NAVIGATOR Phase III trial were published in
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.
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 (
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