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AstraZeneca : FDA Panel Votes Against Approval Of Roxadustat For Anemia

The U.S. Food and Drug Administration's Advisory Committee voted against approval of roxadustat for the treatment of anemia caused by chronic kidney disease in both non-dialysis and dialysis adult patients, AstraZeneca Plc (AZN,AZN.L) said in a statement.

The FDA does not have to follow the recommendations of its advisory committees on approval but usually does.

The FDA's Cardiovascular and Renal Drugs Advisory Committee has voted 13 to 1 that the benefit-risk profile of roxadustat does not support approval for the treatment of anaemia in chronic kidney disease (CKD) in non-dialysis dependent (NDD) adult patients.

The Committee has also voted 12 to 2 that the benefit-risk profile of roxadustat does not support approval for the treatment of anaemia in CKD in dialysis-dependent adult patients.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said, ".. 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."

AstraZeneca and FibroGen are collaborating on the development and commercialisation of roxadustat for the potential treatment of anaemia in the US, China and other countries in the Americas, Australia and New Zealand, as well as Southeast Asia.

Astellas and FibroGen are collaborating on the development and commercialisation of roxadustat for the potential treatment of anaemia in Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East and South Africa.

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