European Commission approves Tezspire for the treatment of severe asthma

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. 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).

Professor Guy Brusselle, Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium, said: “Severe asthma is a complex disease given approximately 60% of patients have multiple drivers of inflammation. With the European approval of Tezspire, a first-in-class biologic acting at the top of the inflammation cascade, we have an opportunity to treat a broader population of patients with severe asthma, fulfilling a high unmet need in this disease."