(RTTNews) - AstraZeneca Plc. (AZN.L, AZN) said Monday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has recommended Trixeo Aerosphere for marketing authorisation in the European Union for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease or COPD.
Trixeo Aerosphere is a single-inhaler, fixed dose triple-combination of formoterol fumarate, a LABA, glycopyrronium bromide, a LAMA, with budesonide, an ICS, and delivered in a pressurised metered-dose inhaler.
Trixeo Aerosphere is approved under the brand name Breztri Aerosphere in Japan, China and the US for patients with COPD.
The recommendation was based on results from the ETHOS Phase III trial in which Trixeo Aerosphere showed a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere and PT009 over 52 weeks.
The recommendation for approval was also supported by data from the KRONOS Phase III trial.
The ETHOS and KRONOS Phase III trials are part of AstraZeneca's ATHENA Phase III clinical trial programme for Trixeo Aerosphere, which included more than 15,500 patients globally across 11 trials.
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