Posted by Michael Wonder on 21 Dec 2018
Bevespi Aerosphere approved in the EU for chronic obstructive pulmonary disease
20 December 2018 - AstraZeneca today announced that the European Commission has approved Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in a pressurised metered-dose inhaler as a maintenance dual bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease.
Bevespi Aerosphere is the first medicine in its class to be approved by the EC in a pMDI. The approval offers patients with COPD an important new choice of inhaler device.
Bevespi Aerosphere is a twice-daily, fixed-dose dual bronchodilator combining glycopyrronium, a long-acting muscarinic antagonist and formoterol fumarate, a long-acting beta2-agonist. The EC approval is based on the Phase III PINNACLE trial programme which evaluated the efficacy and safety of Bevespi Aerosphere and involved more than 5,000 patients with moderate to very-severe COPD.
