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Amgen's blockbuster monoclonal antibody Tezepelumab submitted to BLA, phase III clinical trial has started in China

 Last Update: 2021-05-21
 Source: Internet
 Author: User

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On May 10th, Amgen announced that its partner AstraZeneca has submitted a Biological Agent License (BLA) for Tezepelumab to the US FDA.

TSLP is an epithelial cytokine produced in response to pro-inflammatory stimuli (such as lung allergens, viruses, and other pathogens).

This submission of the BLA is based on the support of the positive results of the PATHFINDER clinical trial, including the pivotal phase 3 clinical NAVIGATOR.

Supported by these results, the FDA granted Tezepelumab a breakthrough therapy designation in September 2018, which is suitable for patients with severe asthma without an eosinophilic phenotype.

NAVIGATOR is the first phase III trial that targets TSLP for the treatment of severe asthma.

According to the Insight database, AstraZeneca has currently carried out 3 clinical trials of Tezepelumab in China.

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