US FDA approves tezepelumab for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with severe asthma

Approval of the human monoclonal antibody that inhibits thymic stromal lymphopoietin, preventing release of pro-inflammatory cytokines, was based on results of the NAVIGATOR Phase 3 trial in which it demonstrated superiority vs placebo in all primary and secondary endpoints.

SPS commentary:

An application seeking approval of tezepelumab in the EU was filed in July 2021.

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Biospace Inc.