The European Commission has approved AstraZeneca’s Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for the treatment of COPD, the company has announced. The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion regarding the MAA for Bevespi Aerosphere in October 2018.
The FDA approved Bevespi Aerosphere in 2016, and the inhaler has also been approved in Canada, Australia, Turkey, and Taiwan.
AstraZeneca Head of Respiratory, Global Medicines Development, Colin Reisner commented, “Bevespi Aerosphere is already available to COPD patients in the US and other countries, and this approval means we can now bring this new medicine to patients in Europe. Bevespi Aerosphere is the first dual-bronchodilator treatment delivered in our next-generation pressurized metered-dose inhaler using Aerosphere Delivery Technology.”
Read the AstraZeneca press release.
