10th May 2019 08:17
LONDON (Alliance News) - AstraZeneca PLC late Thursday said pooled analyses of phase three trials of roxadustat showed the anaemia drug only outperformed in patients who were new to dialysis in terms of cardiovascular safety.
The drug major is working with FibroGen Inc to develop roxadustat, which is intended to treat anaemia in patients with chronic kidney disease. The most recent analyses concerned three different groups: patients who were not dependent on dialysis, patients who had just begun dialysis, and stable dialysis groups. The drug met its cardiovascular safety endpoints in all three groups.
The analyses looked at major adverse cardiovascular events, or MACE, which evaluates all-cause mortality, stroke, and myocardial infarction. The analyses also looked at MACE in addition to heart failure requiring hospitalisation and unstable angina requiring hospitalisation, known as MACE plus.
The MACE and MACE plus outcomes in non dialysis-dependent patients showed no clinically-meaningful difference compared to placebo, which was also true in dialysis-dependent patients.
However, MACE and MACE plus outcomes were better when compared to the drug epoetin alfa in patients who were new to dialysis. Astra considers this group to be a better population for comparing roxadustat to epoetin alfa than a stable dialysis population as stable dialysis patients are also stable on the hormone erythropoietin, which treats anaemia in kidney-disease.
Shares in AstraZeneca were down 1.3% on Friday morning at 5,752.00 pence each in London. On the NASDAQ, Fibrogen lost 15% in after-hours Thursday trading, down at USD38.80.
Mene Pangalos, AstraZeneca's Executive Vice President of Research & Development BioPharmaceuticals said: "These results add to the growing body of positive evidence to support roxadustat for the treatment of anaemia in chronic kidney disease patients, following our announcement that the primary efficacy endpoints were met for the Olympus and Rockies trials in December 2018. There is a significant unmet medical need among patients living with chronic kidney disease, and we look forward to working with FibroGen to prepare for regulatory submissions of roxadustat."
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