European approval for AstraZeneca’s Trixeo Aerospace in moderate to severe COPD

pharmafile | December 14, 2020 | News story | Sales and Marketing AstraZeneca, COPD, EMA, Europe, Trixeo Aerosphere 

The European Medicines Agency (EMA) has announced the approval of AstraZeneca’s Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) in the European Union for the maintenance of moderate to severe chronic obstructive pulmonary disease (COPD).

Specifically, the decision relates to adult COPD patients for whom previous treatment with either the combination of an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA), or a LABA and a long-acting muscarinic antagonist (LAMA), proved ineffective in controlling their condition.

Phase 3 data from the ETHOS trial showed that Trixeo Aerospace generated a “statistically significant reduction” in the rate of moderate or severe COPD exacerbations over 52 weeks compared to dual-combination therapies Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate).

“Chronic obstructive pulmonary disease significantly contributes to morbidity and healthcare resource utilisation in Europe. 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,” explained Klaus Rabe, lead investigator on the ETHOS trial, Professor of Pulmonary Medicine at the University of Kiel, and Director of the Department of Pneumology at Clinic Grosshansdorf in Germany. “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.”

The safety profile for AstraZeneca’s therapy was also found to be in line with previous research and consistent with Bevespi Aerosphere and PT009.

The decision follows a positive recommendation of the product in this indication from the EMA’s Committee for Medicinal Products for Human Use (CHMP) back in October earlier this year.

“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,” added Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca. “In Europe, about one in 10 adults over the age of 40 has chronic obstructive pulmonary disease, with prevalence increasing. We look forward to discussing all-cause mortality data from the ETHOS Phase III trial with health authorities.”

Matt Fellows

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