UPDATE: Positive top-line Phase III data on roxadustat in chronic kidney disease

20 September 2018

Japanese drug major Astellas Pharma (TYO: 4503)today announced that roxadustat, an inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase activity, met its primary endpoints in the Phase III ALPS study by demonstrating superiority in efficacy versus placebo in terms of both hemoglobin (Hb) response rate in the first 24 weeks and Hb change from baseline at Weeks 28 to 52.

The preliminary safety analysis for this trial shows an overall event profile consistent with the results seen in previous roxadustat studies in chronic kidney disease (CKD) patients with anemia.

Astellas’ shares were up 2% at 2,056 yen in morning activity, but eased back by close of trading in Tokyo.

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