AstraZeneca Abandons Roxadustat’s US Future while Retaining Collaboration with FibroGen in China

- AstraZeneca has decided to return the rights for roxadustat, an oral HIF-PH inhibitor treating anemia, to FibroGen in the United States and certain other regions.
- Despite relinquishing rights in the US, AstraZeneca maintains the collaboration agreement with FibroGen for roxadustat in China.
- Roxadustat is approved in China, Japan, several European countries, and others for the treatment of anemia related to Chronic Kidney Disease (CKD).
- FibroGen intends to evaluate options for licensing roxadustat in the US and other territories where it has not yet been approved.
- The clinical development of roxadustat includes studies for chemotherapy-induced anemia and myelodysplastic syndromes.
- A Supplemental New Drug Application for roxadustat in chemotherapy-induced anemia is pending.
- FibroGen anticipates an approval decision in China for chemotherapy-induced anemia later in 2024.
- In 2023, roxadustat net sales in China amounted to $284.1 million.
- FibroGen continues to investigate roxadustat for various indications, believing it represents an important potential therapy for patients in the US and other markets.

These key points summarize the recent development where AstraZeneca withdraws from the US market for roxadustat while retaining ties with FibroGen in China and exploring licensing opportunities elsewhere.