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Roxadustat phase 3 show treatment of anaemia from chronic kidney disease: AstraZeneca, FibroGen

AstraZeneca and FibroGen’s pooled cardiovascular (CV) safety analyses showed that roxadustat, an oral first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), did not increase the risk of MACE, MACE+ and all-cause mortality 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.

In a clinically important predefined subgroup of incident dialysis (ID) patients, defined as patients who have been on dialysis for four months or less, roxadustat reduced the risk of MACE and MACE+ and showed a trend towards lower risk of all-cause mortality relative to epoetin alfa, AstraZeneca said in a press release Monday.

Furthermore, the key safety endpoints consisted of time to major adverse CV events (MACE), defined as all-cause mortality, stroke and myocardial infarction, and time to MACE+, defined as MACE, unstable angina requiring hospitalisation and congestive heart failure requiring hospitalisation.

The results were presented in an oral late-breaking abstract session at the American Society of Nephrology (ASN) Kidney Week 2019 in Washington, D.C., US, the company said.

Mene Pangalos, Executive Vice President, BioPharmaceuticals, R&D, said that 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.

Robert Provenzano, the primary investigator on the global Phase III programme, said that Roxadustat is the first in a new class of medicines for the treatment of anaemia from chronic kidney disease. He said that this pooled cardiovascular safety data, together with strong efficacy data, support its potential as an important new treatment option for patients with anaemia from chronic kidney disease who have seen little to no innovation in decades.

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