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Tezspire recommended for EU approval in asthma
Tezspire recommended for EU approval in asthma.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n 25 July 2022 07:10 BST\n \n \n \n \n \n \n Tezspire\n \n \n recommended for approval in the EU by CHMP for the treatment of\n \n \n severe asthma\n \n \n \n \n \n \n \n First and only biologic recommended for EU approval in patients with severe asthma with no phenotype or biomarker limitations\n \n \n \n \n \n \n \n \n AstraZeneca's Tezspire (tezepelumab) has been recommended for marketing authorisation in the European Union (EU) as an add-on therapy in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.\n \n \n \n \n \n The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the PATHFINDER clinical trial programme. The marketing authorisation\n application included results from 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.1\n \n \n \n \n \n \n Tezspire\n \n is the first and only biologic for severe asthma that acts at the top of the inflammatory cascade by blocking thymic stromal lymphopoietin (TSLP), an epithelial cytokine.1-4Tezspire consistently and significantly reduced asthma exacerbations across Phase II and 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).1,2\n \n \n \n \n \n Dr. Stephanie Korn, Senior Physician in Pneumology and Respiratory Medicine at IKF Pneumologie Mainz and Thoraxklinik Heidelberg, Germany, and investigator for the NAVIGATOR trial said: \"Due to the complexity of severe asthma, about\n 60% of patients have multiple drivers of inflammation. Tezspireis\n a\n first-in-\n class\n biologic acting at the top of the inflammation cascade and a much-needed potential treatment for patients who continue to struggle with severe, uncontrolled asthma\n .\"\n \n \n \n \n \n Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: \"Despite recent advances in treatment, many asthma patients continue to experienc...