Trixeo Aerosphere Approved in EU for COPD

The European Commission has approved AstraZeneca‘s triple combination therapy Trixeo Aerosphere as a maintenance treatment for chronic obstructive pulmonary disease (COPD).

The approval, which follows a positive recommendation from the European Medicines Agency’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 with 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).

“Trixeo Aerosphere has a strong clinical profile compared with dual-combination therapies and offers an important new treatment option for patients with chronic obstructive pulmonary disease,” Mene Pangalos, PhD, executive vice president of biopharmaceuticals R&D at Astrazeneca, said in a press release.

Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) — marketed as Breztri Aerosphere in the U.S., Japan, and China — is a triple combination therapy of the corticosteroid budesonide and two types of bronchodilators: glycopyrronium (a LAMA) and formoterol fumarate (a LABA). Bronchodilators are therapies that dilate and relax the bronchi tissue to ease the flow of air in the lungs.

The therapy, delivered via an inhaler, is meant to reduce the frequency and ease COPD exacerbations — episodes when symptoms suddenly worsen.

The CHMP’s positive recommendation and EU approval was based on data from the Phase 3 clinical trials ETHOS (NCT02465567) and KRONOS (NCT02497001).

In both studies, the effectiveness and safety of Trixeo Aerosphere was compared with the dual combination therapies Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and Symbicort (budesonide/formoterol fumarate), both marketed by AstraZeneca.

The trial’s results showed that the triple combination therapy effectively reduced the frequency of COPD exacerbations when compared to the dual combination therapies. Trixeo Aerosphere had a safety profile similar to the dual combos.

“Even a single exacerbation can cause further deterioration of a patient’s lung function and increase the risk of hospitalisation, so preventing exacerbations is a clinical priority,” Klaus Rabe, MD, PhD, lead investigator of the ETHOS Phase 3 trial, said.

“Trixeo Aerosphere has demonstrated significant benefits in reducing exacerbations in patients with moderate to severe disease, and triple-combination therapy will play an increasingly important clinical role in treating these patients,” added Rabe, who is also a professor of pulmonary medicine at the University of Kiel and director of the pneumology at Clinic Grosshansdorf, Germany.

According to Pangalos, one in 10 adults in Europe over the age of 40 has COPD and the disease’s prevalence is increasing.

“We look forward to discussing all-cause mortality data from the ETHOS Phase III trial with health authorities,” he said.