According to AstraZeneca, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding the marketing authorization application for the company’s Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for the treatment of COPD.
Bevespi Aerosphere was approved by the FDA for marketing in the US in 2016. The MDI is also approved in Canada and Australia.
In August 2018, AstraZeneca announced that the Phase 3b AERISTO of Bevespi Aerosphere for COPD had failed to meet 2 out its 3 endpoints. The company said that the CHMP recommendation was based on data from the Phase 3 PINNACLE studies.
AstraZeneca Head of Respiratory, Global Medicines Development, Colin Reisner commented, “Bevespi Aerosphere is the only fixed-dose long-acting muscarinic antagonist/long-acting beta2-agonist that is delivered in a pressurized metered-dose inhaler. Today’s positive CHMP opinion means COPD patients in Europe are one step closer to having this new dual bronchodilator treatment available to them.”
Read the AstraZeneca press release.
