US-based FibroGen Inc. (NASDAQ: FGEN) has announced positive topline data from a Phase III trial for roxadustat, a treatment for anemia in patients receiving chemotherapy. The study, which focused on 153 patients in China (NCT05301517), showed that detailed results will be presented at a future industry conference.
Roxadustat’s Efficacy and Safety Profile
Topline results indicate that roxadustat demonstrated non-inferiority compared to recombinant erythropoietin alfa (SEPO) on the primary endpoint, which measures the change in hemoglobin (Hb) level from baseline to the average level during weeks 9-13. The adverse event profile was consistent with earlier studies, indicating a positive benefit-risk profile for the drug.
Collaboration with AstraZeneca and Regulatory Submissions
FibroGen states that it will collaborate with AstraZeneca on a New Drug Application to be submitted to the National Medical Products Administration (NMPA). Roxadustat, the first oral hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor globally, is already approved in China, Europe, Japan, and several other markets for the treatment of anemia in chronic kidney disease patients, both on dialysis (DD) and not on dialysis (NDD). FibroGen has partnered with AstraZeneca for China, the US, and markets not licensed to Japan’s Astellas, which is responsible for Japan, Europe, Turkey, Russia, the Commonwealth of Independent States, the Middle East, and South Africa.
Positive Data Impact on FibroGen and AstraZeneca Partnership
The positive data from China’s Phase III trial provides a significant boost to FibroGen and its partnership with AstraZeneca, especially following the recent revelation that roxadustat did not achieve a sufficient improvement to be statistically significant in the Phase III MATTERHORN trial for anemia in myelodysplastic syndrome (MDS) patients.-Fineline Info & Tech
