AZ COPD drug fails to match GSK rival after disappointing launch

AstraZeneca has said it is analyzing “inconsistent” results after a late-stage trial of its Bevespi Aerosphere inhaler in chronic obstructive pulmonary disease (COPD) failed to match the performance of GlaxoSmithKline’s rival. Already approved in the US and on the market since early last year, Bevespi (glycopyrronium/formoterol fumarate) is under review in Europe. While trials used as a basis for approval in the US and Asia have tested Bevespi against placebo, the latest trial, AERISTO was testing to see if it is as effective as GlaxoSmithKline’s rival, Anoro (umeclidinium/vilanterol). Both drugs combine a long-acting muscarinic antagonist (LAMA) and long-acting beta agonist (LABA), and AstraZeneca’s so-called non-inferiority trial was powered to show whether Bevespi could match Anoro at improving peak breathing levels and trough levels. Top-line results showed Bevespi matched Anoro on peak forced expiratory volume in one second (FEV1) but did not demonstrate superiority. It was also worse at improving trough FEV1, according to a statement from AstraZeneca.