FDA assigns PDUFA action date for peginesatide NDA

FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of March 27, 2012, for the review of the New Drug Application (NDA) for the investigational agent peginesatide (formerly known as Hematide). If approved, peginesatide will be the first once-monthly erythropoiesis stimulating agent (ESA) available for the treatment of anemia associated with chronic kidney disease (CKD) in patients on dialysis in the United States.

Peginesatide is a synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an ESA. The NDA included data from two Phase 3 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.

In the studies, more than 1,600 CKD patients on dialysis who were receiving stable doses of epoetin were randomized to receive once-monthly peginesatide or to continue treatment with epoetin. The EMERALD findings suggested that once-monthly peginesatide was comparable to epoetin in maintaining Hb levels in CKD patients on dialysis with anemia, with a similar adverse event rate. The most common adverse events reported in the clinical studies were diarrhea, cough, dyspnea, nausea, and muscle spasm. A similar frequency of serious adverse events was reported between the EMERALD treatment groups.

Affymax and Takeda Pharmaceutical North America are collaborating on the development of peginesatide and plan to market the product jointly if approved in the United States.