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AstraZeneca Reports Results From Cardiovascular Safety Analyses On Roxadustat

British drug major AstraZeneca Plc (AZN.L,AZN) said that pooled analyses of the roxadustat global Phase III programme confirmed cardiovascular safety. Cardiovascular safety endpoints evaluated across chronic kidney disease patients not on dialysis, on incident dialysis and on stable dialysis.

The global pivotal Phase III trials evaluated roxadustat for treatment of anaemia in patients with chronic kidney disease across the non-dialysis-dependent, incident (newly-initiated) dialysis, and stable dialysis patient groups.

In the pooled analysis of over 4,300 patients, and based on the totality of the adjudicated evidence, the MACE/MACE+ analyses between roxadustat and placebo showed no clinically-meaningful difference.

In the pooled analysis of around 4,000 patients, and based on the totality of the adjudicated evidence, the MACE/MACE+ analyses between roxadustat and epoetin alfa showed no clinically-meaningful difference.

AstraZeneca and FibroGen Inc. said they will begin discussions with the US Food and Drug Administration to prepare for regulatory submission, which is anticipated in the second half of 2019. Roxadustat is currently approved in China for the treatment of patients with anaemia in dialysis-dependent chronic kidney disease.

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