East Shines Over West? US Rejection Puts Roxadustat's China Approval In New Spotlight
Japan, EU Offer Other Growth Alternatives?
Touted in China after its first approval globally there for chronic kidney disease-associated anemia back in late 2018, FibroGen/AstraZeneca's roxadustat has now been rejected by the US FDA over cardiovascular safety concerns. But ex-US markets may still enable the drug to shine despite safety wording.
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As anticipated, the FDA issued a complete response letter for roxadustat. While the drug is expected to win EU approval, it is unclear if FibroGen and AstraZeneca will be willing to fund another trial.
But advisory committee members see a potential opportunity for the oral anemia drug in small percentage of dialysis-dependent patients not responsive to erythropoiesis-stimulating agents; FibroGen’s revised dosing algorithm, aimed at slowing hemoglobin rate of increase and reducing risk of thrombosis, needs to be clinically tested before marketing approval, panelists said.