Courier benefits a wide range of severe asthma patients, "first-in-class" antibody therapy is approved by the FDA

▎The content team editor of WuXi AppTec recently announced that Amgen and AstraZeneca have jointly announced that the “first-in-class” antibody therapy Tezspire (tezepelumab-ekko) has been approved by the US FDA as an additional maintenance therapy.
Children over 12 years old and adults with severe asthma
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Tezspire is a monoclonal antibody therapy targeting anti-thymic stromal lymphopoietin (TSLP)
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TSLP is an epithelial cytokine located at the top of multiple inflammatory cascades and initiates an excessive immune response to allergies, eosinophils, and other types of airway inflammation associated with severe asthma
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The US FDA granted tezepelumab breakthrough therapy designation in September 2018 for the treatment of patients with severe asthma without eosinophilic phenotype
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Its application for the marketing of biological products has also been granted priority review by the FDA
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▲TSLP affects the immune response of a variety of immune cells (picture source: reference [2]) This approval is based on a clinical development project called PATHFINDER, including the results of the pivotal phase 3 clinical trial NAVIGATOR
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The results of the NAVIGATOR trial were published in the New England Journal of Medicine in May 2021
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The results of the trial showed that tezepelumab reached all the primary and key secondary endpoints of the trial when treating patients with severe asthma with uncontrolled symptoms
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Compared with placebo, it reduced the annual acute exacerbation rate (AAER) by 56% (p<0.
001)
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The press release pointed out that tezepelumab is the first biological product to consistently and significantly reduce acute exacerbations of asthma in multiple phase 2 and phase 3 clinical trials for patients with severe asthma with a wide range of different characteristics
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The main investigator of the NAVIGATOR trial, Professor Andrew Menzies-Gow of Royal Brompton Hospital, said that due to the complex and heterogeneous characteristics of severe asthma, despite the progress in the development of new drugs, many patients still experience frequent acute exacerbations of the disease and severely reduce the quality of life.
And increase the risk of hospitalization
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Tezspire provides a much-needed new treatment option for severe patients who cannot control their symptoms
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Reference: [1] TEZSPIRE (tezepelumab) Approved in the US for Severe Asthma.
Retrieved December 18, 2021, from https:// Comeau & Ziegler.
( 2009).
The influence of TSLP on the allergic response.
Mucosal Immunology, https://doi.
org/10.
1038/mi.
2009.
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This article is not a treatment recommendation either
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