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Restructuring On The Table For FibroGen After Roxadustat Rejection

 
• By Alaric DeArment

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.

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The FDA issued a complete response letter for FibroGen and AstraZeneca's roxadustat in anemia of chronic kidney disease • Source: Shutterstock

With the US Food and Drug Administration rejecting FibroGen, Inc./AstraZeneca PLC’s roxadustat for anemia in chronic kidney disease (CKD), as expected, FibroGen may be forced to restructure, shifting its attention to Phase III pipeline asset pamrevlumab if the partners choose not to conduct a new clinical trial that could support US approval. Meanwhile, the drug’s setback could create an opening for competitors, particularly GlaxoSmithKline plc’s daprodustat and Akebia Therapeutics, Inc.’s vadadustat.

San Francisco-based FibroGen said 11 August that the FDA issued a complete response letter (CRL), requesting the company and AstraZeneca conduct an additional clinical trial before resubmitting roxadustat for approval

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