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# AstraZeneca BLA for Tezepelumab as Asthma Therapy
- URL: https://www.fdaweb.com/astrazeneca-bla-for-tezepelumab-as-asthma-therapy/
- Published: 2021-05-11T12:00:00.000Z
- Updated: 2026-09-14T16:58:15.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149298

AstraZeneca has submitted a BLA for tezepelumab, a potential first-in-class medicine for treating severe asthma. The submission is supported by data from the PATHFINDER clinical program including the pivotal NAVIGATOR Phase 3 trial, which demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) in patients with severe, uncontrolled asthma compared to placebo, according to development partner Amgen. “Tezepelumab is the only biologic to consistently and significantly reduce AAER in a broad population of severe asthma patients irrespective of the baseline eosinophil counts across Phase 2 and Phase 3 clinical trials,” the company says.

  
Tezepelumab works by targeting and blocking the action of an epithelial cytokine called thymic stromal lymphopoietin, which plays a key role across the spectrum of asthma inflammation, Amgen says. “In NAVIGATOR, tezepelumab demonstrated exacerbation rate reduction irrespective of baseline eosinophil count and improvements in lung function measurements, asthma control and health-related quality of life compared to placebo,” it says.

  
On the safety side, Amgen says the most frequently reported adverse events for tezepelumab were nasopharyngitis, upper respiratory tract infection and headache. Data from the drug development program will be presented at upcoming scientific meetings including the American Thoracic Society 2021 International Conference later this month.