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Amgen/AstraZeneca first in class TSLP inhibitor approved by FDA for marketing

 Last Update: 2021-12-26
 Source: Internet
 Author: User

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On December 17, AstraZeneca and Amgen announced that the US FDA has approved the listing of Tezspire (tezepelumab-ekko) for the additional maintenance treatment of children and adults with severe asthma 12 years of age and older

Thymus stromal lymphopoietin (TSLP) is a key epithelial cytokine, located at the top of multiple inflammatory cascades, and triggers an excessive immune response to airway inflammation related to severe asthma such as allergies and eosinophils

Tezepelumab is a first-in-class human monoclonal antibody that prevents immune cells from releasing pro-inflammatory cytokines by blocking TSLP, thereby preventing asthma attacks and improving asthma control

This marketing application is supported by data from a key phase III clinical study code-named NAVIGATOR, which evaluated the efficacy and safety of tezepelumab + standard therapy (SoC) vs.

At 52 weeks of treatment, compared with placebo, patients in the tezepelumab group had a statistically and clinically significant reduction in AAER

In 2020, Amgen and AstraZeneca updated the 2012 cooperation agreement on tezepelumab

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