FibroGen Announces China FDA Approval of CTA to Conduct Pivotal Phase 2/3 Clinical Trial of Roxadustat in Anemia Associated With Lower Risk MDS

Expands Roxadustat Development Program Into Oncology-Related Anemia in China
SAN FRANCISCO, March 31, 2017 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, today announced the approval by the China Food and Drug Administration (CFDA) of the Company’s clinical trial application (CTA) in China for a Phase 2/3 pivotal trial of roxadustat in anemia associated with lower risk myelodysplastic syndromes (MDS). FibroGen and AstraZeneca (NYSE:AZN) are collaborating on the development and commercialization of roxadustat in China, the U.S., and other major markets. FibroGen is conducting all clinical trials and regulatory submissions in both the U.S. and C…

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