CHMP recommends Bevespi Aerosphere to treat COPD.- AstraZeneca

AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending the marketing authorisation for Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in a pressurised metered-dose inhaler (pMDI) as a maintenance dual bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

The CHMP recommendation is based on the Phase III PINNACLE programme, which demonstrated the efficacy and safety of Bevespi Aerosphere and involved more than 5,000 patients with moderate to very severe COPD. Bevespi Aerosphere is the only fixed-dose long-acting muscarinic antagonist/long-acting beta2-agonist that is delivered in a pressurised metered-dose inhaler. Bevespi Aerosphere is approved in the US, Canada and Australia as a dual bronchodilator for the long-term maintenance treatment of COPD.

Comment: The real value of this recommendation could be the potential for a triple therapy, which would significantly improve patients' treatment regimens, particularly for more severe patients.This is seen in PT 010 (budesonide + formoterol fumarate + glycopyrronium) now in Phase III.