Tezspire approved in the USA for severe asthma

UK-based AstraZeneca (LSE: AZN) and US biotech Amgen’s (Nasdaq: AMGN) Tezspire (tezepelumab-ekko) has been approved in the USA for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma, the companies announced on Friday.

Tezspire was approved following a  Priority Review by the US Food and Drug Administration and based on results from the PATHFINDER clinical trial program. 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). Tezspire is the only biologic approved for severe asthma with no phenotype (eg, eosinophilic or allergic) or biomarker limitation within its approved label.