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CompilationFan Dongdong
On Monday, AstraZeneca and FibroGen said that the FDA will convene an AdComm advisory committee to review the effectiveness of roxadustat in the treatment of anemia in patients with chronic kidney disease who require dialysis and those who do not require dialysis.
AstraZeneca and FibroGen launched a cooperation to develop and market the drug in 2013, involving an upfront payment of US$350 million and a milestone payment of US$465 million.
If approved, roxadustat may be the first oral HIF-PH inhibitor to obtain regulatory approval in the United States.
As the world's first HIF-PHI, roxadustat promotes the production of endogenous erythropoietin, improves the absorption and utilization of iron, reduces hepcidin, and is not affected by the negative influence of inflammation on hemoglobin and erythropoiesis, effectively promoting erythropoiesis.
There are some concerns about the cardiac safety of roxadustat, especially in non-dialysis-dependent patients, but FibroGen and AstraZeneca have largely eliminated these through a pooled analysis of cardiac-related events in their clinical trials.
Mizuho analyst Yang Difei predicted in a report on Tuesday that roxadustat will be approved in two patient groups, but it may be accompanied by a black box warning.
It is worth noting that roxadustat has been approved in China for the treatment of non-dialysis and dialysis-dependent renal anemia.
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