RTTNews | Dec 20, 2021 02:33AM EST

02:33 Monday, December 20, 2021 (RTTNews.com) - AstraZeneca (AZN.L, AZN) and Amgen's Tezspire or tezepelumab-ekko 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.

AstraZeneca noted that Tezspire was approved following a Priority Review by the US Food and Drug Administration (FDA) and based on results from the PATHFINDER clinical trial program.

The application included results from the pivotal NAVIGATOR Phase III trial in whichTezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.

Tezspire is the only biologic approved for severe asthma with no phenotype or biomarker limitation within its approved label.

Tezspire is under regulatory review in the EU, Japan and several other countries around the world.

Read the original article on RTTNews ( https://www.rttnews.com/3250387/astrazeneca-and-amgen-s-tezspire-approved-in-us-for-severe-asthma.aspx)

For comments and feedback: contact editorial@rttnews.com

Copyright(c) 2021 RTTNews.com All Rights Reserved