AstraZeneca partner gets OK from Chinese regulators for dialysis drug

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AstraZeneca announced that its partner FibroGen China now received formal marketing authorization from the National Medical Products Administration for roxadustat, an oral treatment for patients with anemia caused by chronic kidney disease who are on dialysis.

Approval came after a late phase trial.

Anemia (a lack of red blood cells) caused by chronic kidney disease is associated with cardiovascular disease, hospitalization, brain functioning and reduced quality of life.

Anemiabecomes increasingly common among individuals with CKD as their disease progresses, affecting nearly all patients at the dialysis stage.1

Sean Bohen, executive vice president, Global Medicines Development and Chief Medical Officer, said: “Roxadustat is a long-awaited, first-in-class medicine for patients with anemia in chronic kidney disease that are on dialysis. This first approval of roxadustat in China is a significant step towards achieving our ambition to transform care in a condition where prevalence in China is increasing.”

Anemia commonly develops in association with chronic kidney disease and is estimated to affect 120 million patients in China, with an estimated half a million patients on dialysis who may be suffering from anemia, a number that is increasing significantly.2,3

AstraZeneca and FibroGen China are collaborating on the development and commercialization of roxadustat in China.

AstraZeneca and FibroGen expect to launch roxadustat in China during the second half of 2019.

AstraZeneca has its US headquarters near Wilmington and employs about 1,500 northern Delaware.

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