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(Sharecast News) - AstraZeneca, along with its partner FibroGen, presented pooled efficacy and cardiovascular safety analyses from the pivotal phase 3 programme assessing 'roxadustat' on Monday, for the treatment of patients with anaemia from chronic kidney disease (CKD).
The FTSE 100 pharmaceuticals giant said the pooled cardiovascular safety analyses showed that roxadustat - an oral first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor, did not increase the risk of MACE, MACE+ and all-cause mortality in non dialysis-dependent patients compared to placebo, and dialysis-dependent patients compared to epoetin alfa, a current medicine used to treat anaemia.
It said that in a "clinically important" predefined subgroup of incident dialysis patients, defined as patients who had 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.
Key safety endpoints consisted of time to major adverse cardiovascular 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 Kidney Week 2019 in Washington, DC.
"These highly anticipated results reinforce our confidence in 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," said AstraZeneca's executive vice-president of biopharmaceuticals research and development Mene Pangalos.
"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, associate professor of medicine at Wayne State University in Detroit and a primary investigator on the global phase 3 programme, added that roxadustat was the first in a new class of medicines for the treatment of anaemia from chronic kidney disease.
"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."
At 0934 GMT, shares in AstraZeneca were up 0.91% at 7,343p.
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