CHMP recommends Tezspire ,the first and only biologic recommended for EU approval in patients with severe asthma, with no phenotype or biomarker limitations - AstraZeneca

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 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.

Tezspire 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. Tezspire 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).

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 60% of patients have multiple drivers of inflammation. Tezspire is a first-in-class 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.”