A committee from the European Medicines Agency (EMA) recommended that AstraZeneca‘s triple combination therapy Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) be approved as a maintenance treatment for chronic obstructive pulmonary disease (COPD).
The recommendation, from the EMA’s Committee for Medicinal Products for Human Use (CHMP), covers the therapy’s use in adults with moderate-to-severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist (LABA), or a combination of a LABA and a long-acting muscarinic antagonist (LAMA).
The CHMP’s opinion now will be reviewed by the European Commission, which ultimately will decide whether to grant the therapy marketing authorization in the European Union.
“Trixeo Aerosphere has demonstrated strong clinical benefit when compared with dual-combination therapies and this positive recommendation brings us closer to providing a much-needed new treatment to patients in Europe,” Mene Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca, said in a press release.
Trixeo Aerosphere — marketed as Breztri Aerosphere in the U.S., Japan, and China — is a triple combination therapy that contains the corticosteroid budesonide, as well as two types of bronchodilators: glycopyrronium (a LAMA) and formoterol fumarate (a LABA). Bronchodilators are therapies that open the airways by relaxing the lung’s smooth muscle.
The therapy is delivered through an inhaler and is designed to reduce the frequency and ease COPD exacerbations — episodes when symptoms suddenly worsen.
The CHMP’s positive recommendation was based on results from two Phase 3 clinical trials: ETHOS (NCT02465567) and KRONOS (NCT02497001). In both studies, Trixeo Aerosphere was compared against two dual combination therapies based on the same active ingredients as Trixeo Aerosphere. Those therapies were Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and Symbicort (budesonide/formoterol fumarate), both of which also are marketed by AstraZeneca.
Results from both trials demonstrated that the triple combination therapy outperformed the dual combination therapies in terms of lowering exacerbation rates. In terms of safety, Trixeo Aerosphere had a safety profile similar to the dual combos.
“The triple-combination therapy, Trixeo Aerosphere, has demonstrated significant benefits in reducing moderate or severe exacerbations in [people with COPD],” said Klaus Rabe, MD, PhD, a professor of pulmonary medicine at the University of Kiel, Germany.
“Preventing exacerbations is central to the management of chronic obstructive pulmonary disease, as exacerbations may cause irreversible damage and disease progression,” said Rabe, who served as lead investigator of the ETHOS trial and as national coordinating investigator of the KRONOS trial.
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