11th Nov 2019 08:07
(Alliance News) - Pharmaceutical company AstraZeneca PLC on Monday said analyses of a Roxadustat drug trial for the treatment of patients with anaemia from chronic kidney disease showed positive efficacy and no increased risk of major adverse cardiovascular events.
Anaemia is a medical condition in which patients have insufficient red blood cells and low levels of haemoglobin, a protein in red blood cells that carries oxygen to cells throughout the body.
Cambridge-headquartered AstraZeneca, which is collaborating with US-based FibroGen Inc for Roxadustat, said pooled efficacy analyses from Phase III programme showed that roxadustat did not increase the risk of cardiovascular events and all-cause mortality in non dialysis-dependent patients compared to placebo and dialysis-dependent patients and compared to epoetin alfa, a current medicine used to treat anaemia.
Mene Pangalos, AstraZeneca's executive vice president for BioPharmaceuticals research, said: "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."
"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," Pangalos added.
The data from the pooled efficacy and cardiovascular events safety analyses of Roxadustat, together with other statistical analyses, will form part of the regulatory submission in the US, which is anticipated in the final quarter of 2019, AstraZeneca said.
Roxadustat is currently approved in China for the treatment of anaemia in patients with chronic kidney disease, regardless of whether they require dialysis, and in Japan for the treatment of dialysis patients with anaemia from chronic kidney disease.
AstraZeneca shares were up 0.6% early Monday in London at 7,317.00 pence.
By Tapan Panchal; [email protected]
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