AstraZeneca and Amgen’s Tezspire 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 Reviewby 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.
“Today’s positive decision marks the first time the FDA has approved a biologic for asthma without phenotypic limitation and irrespective of biomarker levels. With the approval of Tezspire, physicians will now be able to offer an important new treatment that has the potential to transform care for a broad population of severe asthma patients,” says Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca.
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), states AstraZeneca. Tezspire is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.
In clinical studies, the most common adverse reactions in patients who received Tezspire were pharyngitis, arthralgia and back pain.
Tezspire is under regulatory review in the EU, Japan and several other countries around the world.
Image: Esonophil prior to apoptosis. Natural killer cell being recruited by a biologic. Photo: AstraZeneca