According to AstraZeneca, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the company’s Trixeo Aerosphere 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.
Trixeo Aerosphere is known as Breztri Aerosphere in the US, China, and Japan. Breztri Aerosphere was approved in Japan in June 2019 and in China in December 2019. The FDA approved Breztri Aerosphere for the treatment of COPD in July 2020.
AstraZeneca Executive VP, BioPharmaceuticals R&D, Mene Pangalos commented, “Chronic obstructive pulmonary disease is now the third leading cause of death globally and affects approximately one in 10 adults over the age of 40 in Europe. 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.”
Read the AstraZeneca press release.
