Severe asthma drug Tezspire bags EU approval

Nine months after gaining its first approval in the USA, AstraZeneca’s (LSE: AZN) Tezspire (tezepelumab) has now been approved in the European Union (EU).

Tezspire is cleared for marketing s an add-on maintenance treatment in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product.

The approval by the European Commission was based on results from the PATHFINDER clinical trial program, which included 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.