Tezspire approved in US for severe asthma treatment
AstraZeneca and Amgen's Tezspire (tezepelumab-ekko) has received US approval for severe asthma add-on treatment. The drug is the first biologic approved without phenotype or biomarker limitations.
**The US Food and Drug Administration (FDA) has approved Tezspire (tezepelumab-ekko) as an add-on maintenance treatment for adult and pediatric patients aged 12 and older with severe asthma. The drug is a collaboration between AstraZeneca and Amgen.
The approval follows a Priority Review by the FDA and is based on results from the PATHFINDER clinical trial program. The pivotal NAVIGATOR Phase III trial showed that Tezspire significantly reduced exacerbations compared to placebo across primary and key secondary endpoints when used as an add-on to standard therapy.
Tezspire is a first-in-class biologic for severe asthma that targets thymic stromal lymphopoietin (TSLP), acting at the top of the inflammatory cascade. It is the first and only biologic approved for severe asthma that has consistently and significantly reduced exacerbations in a broad population of patients, irrespective of key biomarkers such as blood eosinophil counts, allergic status, or fractional exhaled nitric oxide (FeNO).
This approval, without phenotype or biomarker limitations, marks a significant advancement. Many patients with severe asthma continue to experience frequent exacerbations and reduced quality of life despite current treatments. Tezspire offers a new treatment option for a wide range of severe asthma patients.