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AstraZeneca and FibroGen face FDA rejection of anaemia drug

Published: 07:32 16 Jul 2021 BST

AstraZeneca -

AstraZeneca PLC (LON:AZN) faces rejection from the US drug regulator for its application for a novel new drug to treat anaemia resulting from chronic kidney disease (CKD).

The Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee voted against approving Roxadustat on the basis of its benefit-risk profile for both non-dialysis dependent and dialysis-dependent adult patients.

Before the committee’s meeting the FDA issued a briefing document that said the drug’s safety in CKD patients was the main issue, with possibly elevated risk of blood clots and seizures.

Regulators in other countries, including Chile, China, Japan and South Korea, have approved Roxadustat for the treatment of anaemia in chronic kidney disease in both sets of adult patients, following Phase III trials in more than 8,000 patients.

The FDA has not announced when it will make its final decision for the roxadustat drug application.

Roxadustat is a partnership with FibroGen Inc (NASDAQ:FGEN), which first developed the drug.

Mene Pangalos, the FTSE 100 company’s executive vice president for biopharmaceuticals R&D, said: "New solutions are needed for the six million people in the US affected by anaemia of chronic kidney disease. Although we are disappointed by today's outcome, we will continue to work closely with our partner FibroGen and the FDA to determine the path forward for Roxadustat."

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