Blow To AZ As FDA Rejects COPD Contender

Issued with a complete response letter from the FDA, the company says it will now submit newer data showing the combination's effects on exacerbations.

AZCambridge_HQ — AstraZeneca's new respiratory franchise, like its HQ, is under construction • Source: AstraZeneca

AstraZeneca PLC’s goal of challenging GlaxoSmithKline PLC's lead in chronic obstructive pulmonary disease has been dealt a blow after the US Food and Drug Administration rejected its new triple therapy combination, PT010.

Also known as Breztri Aerosphere in Japan, where the drug was approved in June, the company has disclosed that the...