A biopharmaceutical company, Affymax, Inc. and Takeda Pharmaceutical Company Limited reported that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 15 to 1, with 1 abstention, that peginesatide demonstrated a favourable benefit/risk profile for use in the treatment of dialysis patients with anaemia due to chronic kidney disease (CKD).

Peginesatide is a synthetic PEGylated peptidic compound that binds to and stimulates the erythropoietin receptor and thus acts as an ESA. The peginesatide phase 3 clinical programme was the largest to support the new drug application of an ESA in the treatment of anaemia in CKD and the first to prospectively evaluate the cardiovascular safety of an ESA via an analysis of independently adjudicated cardiovascular events. The compound was discovered by Affymax and is being co-developed by Affymax and Takeda. If approved, peginesatide may be the first once-monthly product for anaemia in CKD for dialysis patients available in the United States.

"We're encouraged by the panel's positive view of the benefit/risk profile of peginesatide in the dialysis setting," said John Orwin, president and CEO of Affymax. "Anaemia affects many patients in the dialysis setting, and we look forward to working with the FDA as they complete their evaluation of peginesatide. As a once-monthly treatment, peginesatide, if approved, has the potential to be an important option in the management of anaemia in patients living with this condition."

While the FDA is not bound by the recommendations of its advisory committees, their guidance will be considered by the FDA in its review of the New Drug Application (NDA) that was submitted for peginesatide in May 2011. The scheduled Prescription Drug User Fee Act (PDUFA) date for peginesatide is March 27, 2012.

"Today's ODAC vote represents an important step in the peginesatide New Drug Application review process," said Azmi Nabulsi, MD, president, Takeda Global Research & Development Center, Inc. "As we heard from the discussion today, limited therapeutic options are available for the treatment of anaemia in dialysis patients with chronic kidney disease. Affymax and Takeda will continue efforts to make this alternative available to dialysis patients and the providers who treat them."