FDA Agrees to Review NDA for Peginesatide

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The FDA has agreed to review a New Drug Application (NDA) for peginesatide for the treatment of anemia associated with chronic kidney disease (CKD) in adult dialysis patients, according to a joint announcement by the two companies colloraborating on the development of the drug.

If approved, peginesatide will be the first once-monthly erythropoiesis-stimulating agent (ESA) available for this indication in the United States.

Affymax, Inc., of Palo Alto, Calif., and Takeda Global Research & Development Center, Inc., U.S., of Deerfield, Ill., are developing the medication, which was formerly called Hematide.

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 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.

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