EC Approves AstraZeneca’s Tezspire for Severe Asthma
The European Commission (EC) has approved AstraZeneca’s Tezspire (tezepelumab) 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.
Tezspire is the first biologic approved in Europe for severe asthma. It acts by blocking a cytokine that is key in the initiation and persistence of allergic, eosinophilic and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.
The approval followed a recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use in July.
The drug was developed in a collaboration with AstraZeneca and Amgen that dates back to 2012.
AstraZeneca and Amgen’s Tezspire (tezepelumab-ekko) in December, 2021, has been approved in the US for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with severe asthma.
Tezspire was approved following a Priority Review by the US Food and Drug Administration (FDA) and based on results from the PATHFINDER clinical trial programme. The 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 a first-in-class biologic for severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine. It is the first and only biologic to consistently and significantly reduce 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)
September 22, 2022
