Drug news
Affymax and Takeda submit NDA for Hematide
Affymax Inc. and Takeda Pharmaceutical Company Limited announced the submission of a New Drug Application (NDA) to the FDA for the investigational agent peginesatide (formerly known as Hematide) for the treatment of anemia associated with chronic renal failure (CRF) in adult patients on dialysis. The NDA includes data from two Phase III studies (EMERALD 1 and 2) that evaluated the efficacy and safety of peginesatide, dosed once every four weeks, compared to epoetin alfa or epoetin beta, dosed more frequently (according to the product labels), in maintaining hemoglobin (Hb) levels.
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