FibroGen May Have A New Opening For Roxadustat In The US
Executive Summary
The company announced positive Phase II data for roxadustat in chemotherapy-induced anemia.
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European Approval For Roxadustat Is Silver Lining For FibroGen
The EU approval is good news for FibroGen and marketing partner Astellas, but was expected, and still leaves it pondering its future after FDA knock-back.
Restructuring On The Table For FibroGen After Roxadustat Rejection
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.
FibroGen’s Roxadustat Rejected By US FDA Panel Due To Safety Concerns, Untested Dosing Strategy
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.