Affymax, Inc. (AFFY) and Takeda Global Research & Development Center, Inc. Announce Phase 3 Trials Meet Primary Endpoints for Investigational Drug, Hematide(TM)/peginesatide, to Treat Anemia in Chronic Renal Failure With Some Differences Noted in Secondary Analyses
6/21/2010 9:04:47 AM
PALO ALTO, Calif. & DEERFIELD, Ill. & OSAKA, Japan--(BUSINESS WIRE)--Affymax, Inc. (Nasdaq:AFFY) and Takeda Global Research & Development Center, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE, 4502), today announced preliminary top-line results from the Phase 3 clinical program for the investigational drug, Hematide™/peginesatide, for the treatment of anemia in chronic renal failure patients. The primary efficacy endpoint, the mean change in hemoglobin (Hb) from baseline, in each of the four Phase 3 studies (EMERALD 1, EMERALD 2, PEARL 1 and PEARL 2) met the statistical criteria for non-inferiority, when Hematide was compared to epoetin and darbepoetin, in correcting and/or maintaining Hb in the target range. Hematide also met the statistical criterion for non-inferiority in the combined four studies for the adjudicated cardiovascular composite safety endpoint (CSE), which was composed of death, stroke, myocardial infarction, congestive heart failure, unstable angina, and arrhythmia (hazard ratio (HR) 1.06, 90 percent confidence interval (CI) 0.91 – 1.22). The median duration of follow-up for patients on study drug in the four trials was 1.3 years.