EU approves Trixeo triple-combination inhaler for asthma
The European Commission has approved AstraZeneca's fixed-dose triple-combination inhaler Trixeo Aerosphere as a maintenance treatment for asthma in patients aged 12 and older who remain uncontrolled on a medium-dose inhaled corticosteroid plus a long-acting beta2-agonist. The approval, based on positive KALOS and LOGOS phase 3 trial results and a CHMP positive opinion, marks the first and only EU approval of a triple-combination therapy independent of exacerbation history. Trials showed a rapid lung function improvement within five minutes after the first dose, and the therapy is not a replacement for rescue inhalers.
First single-inhaler triple therapy approved in EU for patients 12 and older
Context
The CHMP gave a positive opinion after phase 3 trial results. The European Commission then approved the medicine. Other regulatory reviews, such as in China, could follow.
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