AstraZeneca Severe Asthma treatment Tezspire gets nod in EU
Tezspire (tezepelumab) is being developed by AstraZeneca in collaboration with Amgen.;
UK: AstraZeneca has recently announced that Tezspire (tezepelumab) has been approved in the European Union (EU) as an add-on maintenance treatment in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product.
The approval by the European Commission was based on results from the PATHFINDER clinical trial programme, which included the pivotal NAVIGATOR Phase III trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy. The approval follows the recommendation by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in July 2022.
"Tezspire is the first and only biologic approved in Europe for severe asthma that acts at the top of the inflammatory cascade by blocking thymic stromal lymphopoietin (TSLP), an epithelial cytokine, claims the company.
Tezspire consistently and significantly reduced asthma exacerbations across the PATHWAY Phase II and the NAVIGATOR Phase III clinical trials, which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide (FeNO).
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