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# AstraZeneca Asthma Priority BLA Accepted
- URL: https://www.fdaweb.com/astrazeneca-asthma-priority-bla-accepted/
- Published: 2021-07-08T12:00:00.000Z
- Updated: 2026-09-14T17:05:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149667

FDA has accepted for priority review an AstraZeneca BLA for tezepelumab for treating asthma. The BLA is based on data from the PATHFINDER clinical trial program, including results from the pivotal NAVIGATOR Phase 3 trial in which tezepelumab demonstrated superiority across every primary and key secondary endpoint compared to placebo in a broad population of patients with uncontrolled asthma while receiving treatment with medium- or high-dose inhaled corticosteroids plus at least one additional controller medication with or without oral corticosteroids, the company says. There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in the trial, it adds.  

Tezepelumab, which is being developed in collaboration with Amgen, is a potential first-in-class human monoclonal antibody that inhibits the action of TSLP, “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,” AstraZeneca says. “TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles. Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity. Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control.”