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ARTICLE | Clinical News

Roxadustat meets in Phase III for CKD patients with anemia not on dialysis

September 21, 2018 4:37 PM UTC

Astellas Pharma Inc. (Tokyo:4503) said roxadustat (ASP1517, FG-4592) met both primary endpoints in the Phase III ALPS trial to treat anemia in patients with chronic kidney disease (CKD) who were not receiving dialysis.

On the primary endpoint for a U.S. submission, thrice-weekly roxadustat significantly improved hemoglobin response rate through week 24 vs. placebo. On the primary endpoint for an EU submission, roxadustat led to significant increases in hemoglobin from baseline to the mean of weeks 28-52, regardless of rescue therapy, vs. placebo...