Hit by surprise setback, AstraZeneca scrambles to explain why its two-in-one COPD inhaler was beaten by GSK rival

AstraZeneca was expecting a Phase IIIb trial to put its two-in-one COPD inhaler on top of GlaxoSmithKline’s rival product. Instead, it was hit by a troubling setback.

Colin Reisner

The company reported that while Bevespi Aerosphere (glycopyrronium/formoterol fumarate) didn’t do worse than GSK’s Anoro (umeclidinium/vilanterol) on peak forced expiratory volume in one second (FEV1), it didn’t do better either. And on trough FEV1, the other co-primary endpoint, AstraZeneca’s inhaler performed worse.

Bevespi Aerosphere, a twice daily inhalation, is already approved in the US and Canada for moderate to severe chronic obstructive pulmonary disease, with a solid set of Phase III data establishing its efficacy (compared to its components and placebo).

“The performance of Bevespi Aerosphere in AERISTO is inconsistent with previous data,” said Colin Reisner, head of respiratory, global medicines development. “A full analysis is underway to understand and characterise these findings and will be presented at a forthcoming medical meeting.”

Overcoming GSK’s lbig ead in the field remains the biggest challenge for AstraZeneca, which is also developing a three-in-one inhaler to rival GSK’s big once-daily triple COPD therapy Trelegy Ellipta, a treatment with a big head start and an easier dosing regimen.

Earlier this year, AstraZeneca offered an encouraging look at some Phase III data for PT010 that they plan on using in regulatory submissions in Japan and China. Readout for another trial is due in 2019, at which point the company might file NDAs in the US and the EU.

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