The European Commission has approved AstraZeneca’s Bevespi Aerosphere in the European Union for the treatment of COPD using a pressurized metered-dose inhaler. The drug has been approved for use in the US since April 2016.
The EC’s approval was based on a phase three Pinnacle trial program of more than 5,000 patients with COPD.
COPD is the name given to a group of lung conditions including emphysema and chronic bronchitis. Symptoms include breathlessnesses, coughing, wheezing, and chest infections, and it affects an estimated 384 million people worldwide.
“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 pressurised metered-dose inhaler using Aerosphere delivery technology,” said Astra Respiratory Global Medicines Head Colin Reisner.