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FibroGen Announces Completion of Enrollment in U.S. Phase 3 Clinical Program for Roxadustat
Jun. 07, 2018 08:33AM PST
Pharmaceutical InvestingFibroGen (NASDAQ:FGEN), a biopharmaceutical company, today announced the completion of patient enrollment in the Phase 3 studies supporting the U.S. new drug application (NDA) submission for roxadustat in anemia associated with chronic kidney disease (CKD). The Phase 3 clinical program is evaluating the use of roxadustat for the treatment of anemia in both dialysis-dependent and non-dialysis-dependent …
FibroGen (NASDAQ:FGEN), a biopharmaceutical company, today announced the completion of patient enrollment in the Phase 3 studies supporting the U.S. new drug application (NDA) submission for roxadustat in anemia associated with chronic kidney disease (CKD). The Phase 3 clinical program is evaluating the use of roxadustat for the treatment of anemia in both dialysis-dependent and non-dialysis-dependent CKD patients.
As quoted in the press release:
“We are pleased to have achieved this critical step in our roxadustat Phase 3 clinical program, and we look forward to reporting topline results from these studies by the end of this year, with pooled safety analyses available in 2019,” said K. Peony Yu, Chief Medical Officer, FibroGen. “The results of these studies will support the submission of an NDA in the first half of 2019.”
A total of approximately 9,000 CKD patients were enrolled across the seven studies sponsored by FibroGen and its partners Astellas Pharma Inc. and AstraZeneca in both dialysis-dependent patients and non-dialysis-dependent patients. Subpopulations of interest include patients initiating dialysis (incident dialysis) and patients with inflammation.