16th Jul 2021 08:23
(Alliance News) - Drugmaker AstraZeneca PLC on Friday said a Food & Drug Administration committee voted against approving the use of its roxadustat drug for treating kidney disease.
The US regulator decided that the benefit-risk profile of roxadustat does not support approval for the treatment of anaemia in chronic kidney disease in non-dialysis dependent adult patients.
The US FDA's Cardiovascular & Renal Drugs Advisory Committee also said that the benefit-risk profile of roxadustat does not support approval for the treatment of anaemia in chronic kidney disease in dialysis-dependent adult patients.
"New solutions are needed for the six million people in the US affected by anaemia of chronic kidney disease," said Mene Pangalos, executive vice president at Astra's BioPharmaceuticals R&D.
"Although we are disappointed by today's outcome, we will continue to work closely with our partner FibroGen and the US FDA to determine the path forward for roxadustat."
AstraZeneca said that the safety of roxadustat has been demonstrated in clinical trials involving more than 8,000 patients and published in five peer-reviewed journal articles.
Shares in AstraZeneca were trading down 0.9% at 8,268.56 pence each in London on Friday morning.
By Will Paige; [email protected]
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