Tezspire is a maintenance therapy for patients with no phenotype or biomarker limitations

AstraZeneca’s Tezspire – also known as Tezepelumab – has been approved in the 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 study, which included the pivotal NAVIGATOR phase 3 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 biologic approved in Europe for severe asthma that acts at the top of the inflammatory cascade by blocking thymic stromal lymphopoietin. Furthermore, the treatment significantly reduced asthma exacerbations across the PATHWAY phase 2 and the NAVIGATOR phase 3 clinical trials, which included a broad population of severe asthma patients irrespective of key biomarkers.

Professor Guy Brusselle, Department of Respiratory Medicine at Ghent University Hospital, reflected: “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."

Mene Pangalos, executive vice president, BioPharmaceuticals R&D at AstraZeneca, concluded: “Severe asthma continues to have a debilitating impact for people living with the disease, with many patients experiencing frequent exacerbations, an increased risk of hospitalisation and a significantly reduced quality of life.”