FibroGen May Have A New Opening For Roxadustat In The US

The company announced positive Phase II data for roxadustat in chemotherapy-induced anemia.

Two Roads — FibroGen could have another path to take forward for roxadustat • Source: Alamy

Just weeks after FibroGen, Inc.'s lead asset roxadustat failed to win approval from the US Food and Drug Administration for anemia in chronic kidney disease, the company announced positive clinical trial data for the drug in a different indication, chemotherapy-induced anemia. The results of the Phase II WHITNEY trial released on 25 August could provide an opportunity for FibroGen to pivot to the chemotherapy-induced anemia indication in the US.

Earlier in August, FDA issued a complete response letter (CRL) for roxadustat in CKD – a big disappointment for FibroGen...

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