AZ COPD drug fails to match GSK rival after disappointing launch

AstraZeneca has said it is analysing “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.

The results will be a further disappointment for AstraZeneca, as sales of Bevespi have been lower than the firm expected since its launch in the US early last year – full year results showed it produced revenues of just $16 million.

Things have not improved significantly since then – in the first half of 2018 sales were $13 million, with $8 million of these revenues coming in the last quarter.

AstraZeneca said that sales of the overall LAMA/LABA class in the US have grown at a slower pace than expected.

Colin Reisner

Colin Reisner

Dr Colin Reisner, head of respiratory, global medicines development at AstraZeneca, said: “The efficacy and safety of Bevespi Aerosphere has been established by the phase III PINNACLE trial programme involving more than 5,000 patients.

“The performance of Bevespi Aerosphere in AERISTO is inconsistent with previous data. A full analysis is underway to understand and characterise these findings and will be presented at a forthcoming medical meeting.”

There was no word from the company about whether the results will affect the European review of Bevespi Aerosphere, which is due to conclude in the coming months following a filing last autumn.

AstraZeneca acquired the drug when it bought the California biotech Pearl Therapeutics for $1.15 billion in 2013.

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.