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AZN And Amgen's Tezepelumab Reduces Exacerbations In Patients With Severe, Uncontrolled Asthma

AstraZeneca (AZN.L,AZN) and Amgen's (AMGN) tezepelumab demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate in severe, uncontrolled asthma patients, as per the pivotal NAVIGATOR Phase III trial.

Tezepelumab is a potential first-in-class human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and other types of airway inflammation associated with severe asthma.

The companies stated that Tezepelumab demonstrated superiority versus placebo across every primary and key secondary endpoint in the late-stage trial. This include lung function measurements, asthma control, and health-related quality of life.

Tezepelumab, a potential first-in-class medicine, when added to standard of care achieved a 56% reduction in annualized asthma exacerbation rate over 52 weeks in the overall patient population, compared to placebo when added to standard of care.

According to the companies, Tezepelumab is the only biologic medicine to consistently and significantly reduce annualized asthma exacerbation rate in a broad population of severe asthma patients irrespective of baseline eosinophil count across Phase II and Phase III clinical trials.

Tezepelumab blocks the action of thymic stromal lymphopoietin (TSLP), an epithelial cytokine that plays a key role across the spectrum of asthma inflammation. NAVIGATOR is the first Phase III trial to show benefit in severe asthma by targeting TSLP.

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