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TEZSPIRE® (tezepelumab) Efficacy Profile & Clinical Trials

  • Clinical trials
  • —  NAVIGATOR study
  • —  PATHWAY study
  • Efficacy results
  • Study design and endpoints overview

The NAVIGATOR Study

Over 52 weeks in patients > 12 years old with severe asthma with both treatment arms as an add-on to background asthma therapy,

TEZSPIRE® demonstrated statistically significant and clinically meaningful reductions in AAER requiring ER visits/hospitalization vs. placebo (secondary endpoint)1*

TEZSPIRE® demonstrated statistically significant and clinically meaningful reductions in AAER requiring ER visits/hospitalization vs. placebo (secondary endpoint)1*

Fictitious patients. May not be representative of general population.

Key secondary endpoints for the NAVIGATOR study1

Change from baseline in:

  • Pre-dose pre-bronchodilator FEV1
  • ACQ-6
  • AQLQ(S)+12

In the NAVIGATOR trial, various factors such as treatment, geographical region, age group, and the participant’s history of exacerbations (flare-ups) were included as covariates for the rate of asthma exacerbations.

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* The annual asthma exacerbations and exacerbations requiring emergency room visit/hospitalization were analyzed through a negative binomial regression model, with the logarithm of time at risk included as an offset variable. Rates are the total number of asthma exacerbations in each group/total person-year follow-up in each group with exact Poisson confidence intervals. In NAVIGATOR, estimated marginal rates are presented from the model. AAER, annualized asthma exacerbations rate; ACQ-6, Asthma Control Questionnaire 6; AQLQ(S)+12; Standardised Asthma Quality of Life Questionnaire for ages 12 and older; 
    

CI, confidence interval; ER, emergency room; FEV1, forced expiratory volume in one second; RR, rate ratio

Reference:

  1. AstraZeneca Canada Inc. TEZSPIRE® Product Monograph. 2024.  

Last reviewed: Sept 2024

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TEZSPIRE® and the logo are trademarks of Amgen Inc. and the Amgen logo is a registered trademark of Amgen Inc., used under license by AstraZeneca Canada Inc.

CA-8885E. Last updated 10/24

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AstraZeneca and the AstraZeneca logo are registered trademarks of AstraZeneca AB, used under license by AstraZeneca Canada Inc.

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TEZSPIRE® and the logo are trademarks of Amgen Inc. and the Amgen logo is a registered trademark of Amgen Inc., used under license by AstraZeneca Canada Inc.

CA-8885E. Last updated 06/24

© 2024 AstraZeneca Canada Inc. All rights reserved.

AstraZeneca and the AstraZeneca logo are registered trademarks of AstraZeneca AB, used under license by AstraZeneca Canada Inc.

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