AstraZeneca’s fixed-dose triple-combination Trixeo Aerosphere (Trixeo) has been recommended for approval in the EU for the maintenance treatment of asthma in patients 12 years of age and older.
Trixeo, marketed as Breztri Aerosphere in the US, China and Japan, is a single inhaler that combines the efficacy of ICS/LABA with a long-acting muscarinic antagonist (LAMA). It is suitable for people who are not adequately controlled by a combination of a medium dose inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA).
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the KALOS and LOGOS phase 3 trials, in which Trixeo demonstrated statistically significant improvements in lung function compared with combined ICS/LABA comparators.
Asthma is a prevalent, chronic respiratory disease affecting as many as 363 million people worldwide, including nearly 43 million people in Europe, with about four million more people being newly diagnosed each year. When uncontrolled on dual therapies, patients can often struggle with symptoms such as wheezing, breathlessness and coughing exacerbations.
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “Building on the recent FDA approval for Breztri/Trixeo in asthma, we are pleased by the positive CHMP recommendation, which underscores the potential of this fixed-dose triple-combination therapy to improve outcomes for patients in Europe who continue to experience uncontrolled disease.”
Trixeo/Breztri, is approved in the US for treatment of asthma, with regulatory filings currently under review in other major regions, including Japan and China. Trixeo/Breztri is also approved for the treatment of COPD in adults in 90 countries worldwide including the US, EU, China and Japan.