Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Company Limited (TSE:4502), today announced that the companies have decided on a preliminary strategic path forward for the investigational drug, Hematide™/peginesatide, for the treatment of anemia in chronic renal failure patients in the United States.
Affymax and Takeda 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. Before year end, 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.
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