The EU has approved AstraZeneca’s Trixeo Aerosphere (PT010) formoterol fumarate / glycopyrronium bromide / budesonide MDI for the treatment of patients with moderate to severe COPD that is not treated adequately an ICS/LABA or LABA/LAMA combination, the company said. The EMA’s CHMP had adopted a positive opinion regarding the MAA for Trixeo Aerosphere in October 2021.
In the US, China, and Japan, the formoterol / glycopyrronium / budesonide MDI is called Breztri Aerosphere. The FDA approved Breztri Aerosphere for the treatment of COPD in July 2020; the inhaler was approved in Japan in June 2019 and in China in December 2019.
AstraZeneca Executive VP, BioPharmaceuticals R&D, Mene Pangalos commented, “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. 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 3 trial with health authorities.”
Read the AstraZeneca press release.
