European Approval For Roxadustat Is Silver Lining For FibroGen
But Will Not Head Off Restructuring
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.
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The company announced positive Phase II data for roxadustat in chemotherapy-induced anemia.
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.
AstraZeneca and FibroGen hit another safety roadblock with roxadustat, while GSK is hoping it might catch up with its rivals in the US.