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AstraZeneca: Roxadustat Phase III Pooled Analyses Show Positive Efficacy

AstraZeneca plc (AZN.L,AZN) and FibroGen Inc. have reported pooled efficacy and cardiovascular safety analyses from the Phase III programme assessing roxadustat for the treatment of patients with anaemia from chronic kidney disease. The company said the results demonstrated the potential of roxadustat to address significant unmet medical needs among patients with anaemia from chronic kidney disease, particularly for those who have recently started dialysis.

The primary efficacy endpoint was achieved in the pooled analyses for non dialysis-dependent and dialysis-dependent patients, and in all individual Phase III trials. The study data will form part of the regulatory submission in the US, which is anticipated in the fourth quarter of 2019.

Mene Pangalos, Executive Vice President, BioPharmaceuticals, R&D, said: "The pooled analyses showed incident dialysis patients receiving roxadustat had a lower risk of cardiovascular events which is important as these patients may experience higher rates of morbidity and mortality than those on stable dialysis."

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