Amgen Says, 'Tezepelumab Reduced Exacerbations Requiring Hospitalization By 85%'

Amgen (AMGN) and AstraZeneca Thursday said results from the Phase 3 study of tezepelumab in severe asthma patients, dubbed Navigator, have been published in the New England Journal of Medicine.

The latest results from the study showed that tezepelumab reduced annualized asthma exacerbation rates (AAERs) by 77% in patients with elevated baseline blood eosinophil counts and fractional exhaled nitric oxide (FeNO) levels. High levels of eosinophils in blood shows asthma is more severe and high FeNO levels signals inflammation in the lungs.

The data from the Navigator trial also revealed that tezepelumab reduced exacerbations requiring hospitalizations, by 85%.

These results build on the Navigator data presented in February 2021, that showed a statistically significant reduction in AAER in patients treated with tezepelumab compared to placebo, irrespective of blood eosinophil counts, allergy status or FeNO level.

"Managing severe asthma is challenging with multiple inflammatory pathways often contributing to the complexity of a patient's disease. These latest results underscore the potential of tezepelumab to transform treatment for a broad population of severe asthma patients regardless of their type of inflammation," said Professor Andrew Menzies-Gow, Director of the Lung Division, Royal Brompton Hospital, London, UK, and principal investigator of the NAVIGATOR Phase 3 trial.

The detailed results from the Navigator study will be presented at the American Thoracic Society (ATS) conference this week. Further results from the Pathfinder clinical trial program, primary analyses from the Source Phase 3 and Cascade Phase 2 studies also will be presented at the conference.

On May 10, Amgen had announced that its partner AstraZeneca submitted a Biologics License Application (BLA) to the Food and Drug Administration for tezepelumab.

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