Archived article
Please note that tax, investment, pension and ISA rules can change and the information and any views contained in this article may now be inaccurate.
AstraZeneca said pooled analyses had shown that its drug used to treat patients with anaemia from chronic kidney disease had met its primary goal with no increased cardiovascular risk.
The pooled cardiovascular (CV) safety analyses showed that roxadustat did not increase the risk of major adverse CV events in non dialysis-dependent (NDD) patients compared to placebo and dialysis-dependent (DD) patients compared to epoetin alfa, a current medicine used to treat anaemia, AstraZeneca said.
'The primary efficacy endpoint was achieved in the pooled analyses for NDD and DD patients, and in all individual phase III trials,' it added. 'Data from the pooled efficacy and CV safety analyses, together with other statistical analyses, will form part of the regulatory submission in the US, which is anticipated in the fourth quarter of 2019.'