FDA assigns PDUFA action date for review of Affymax peginesatide NDA

Affymax, Inc. (Nasdaq: AFFY) today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of March 27, 2012 for the review of the investigational agent peginesatide (formerly known as Hematide™) New Drug Application (NDA). The company had announced on July 27, 2011 that the FDA accepted the peginesatide NDA submission for review.

If approved, peginesatide will be the first once-monthly erythropoiesis stimulating agent (ESA) available for the treatment of anemia associated with CKD 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, over 1,600 CKD patients on dialysis who were receiving stable doses of epoetin were randomized to receive once-monthly peginesatide or 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.

"To date, limited options exist for treating anemia in chronic kidney disease patients on dialysis," said John Orwin, chief executive officer of Affymax. "The peginesatide New Drug Application represents an important step in the evaluation of this potential new treatment for the many dialysis patients impacted by this common condition."