AstraZeneca asthma drug gets EU marketing approval
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AstraZeneca's asthma treatment Tezspire has been recommended for marketing authorisation in the European Union as an add-on therapy in patients 12 years and older, the company said.
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The treatment helps patients with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the PATHFINDER clinical trial programme.
Results from the pivotal NAVIGATOR Phase III trial showed Tezspire “demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy”, AstraZeneca said.