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AZ, Amgen file first-in-class asthma drug with the FDA

AZ, Amgen file first-in-class asthma drug with the FDA

May 11, 2021

Via: PMLiVE
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AZ and Amgen are seeking approval for tezepelumab for the treatment of severe asthma patients, based on results from the companies’ PATHFINDER clinical programme.

This includes data from the pivotal phase 3 NAVIGATOR trial, which demonstrated that tezepelumab achieved a 56% reduction in the annual asthma exacerbation (AAER) rate over 52 weeks in the overall patient population when added to standard of care (SoC).

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