PALO ALTO, Calif.—Affymax Inc. and Takeda Pharmaceutical Company Limited said Aug. 5 they are looking to submit an approval application for their anemia drug Hematide to the U.S. Food and Drug Administration by the first half of 2011.
The investigational drug Hematide is being studied to treat anemia in chronic renal failure patients in the United States.
Affymax and Takeda said they are continuing to conduct further analysis of the PEARL and EMERALD studies which evaluated the efficacy and safety of Hematide in chronic renal failure patients with anemia.
By the end of 2010, the companies plan to discuss with the FDA the U.S. registration strategy for Hematide. Subject to feedback from the FDA, the plan is to pursue a new drug application (NDA) for treatment of anemia in dialysis patients, while continuing to evaluate the non-dialysis indication.
The timeline for possible submission of the NDA will be aimed for first half of 2011, but will be finalized after the FDA meeting.
As previously announced, 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, according to Affymax.
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.
The Hematide Phase 3 program, which involved 2,609 randomized patients, consisted of four open-label, randomized active-controlled clinical trials in the United States and Europe, including two studies in non-dialysis patients (PEARL 1 and 2) and two others in dialysis patients (EMERALD 1 and 2).
In all studies, Hematide was dosed once every four weeks while comparator drugs were dosed more frequently according to their product labels. In these studies, epoetin was dosed one-to three-times per week and darbepoetin was dosed every two weeks. The Hb target range was 11-12 g/dL for non-dialysis patients and 10-12 g/dL for those on dialysis.
