An advisory panel to the FDA has voted 15-1 that the benefits of the erythropoiesis stimulating agent peginesatide (formerly known as Hematide) outweighed its risks for the treatment of anaemia in dialysis patients. The FDA usually follows the advice of its advisory panels, and is set to make the final decision on peginesatide in March 2012.

Late-stage trials of peginesatide released in June, met their main goal but showed a higher rate of cardiovascular events, including death and stroke, in patients with chronic renal failure who were not on dialysis. This led the company to seek approval of the drug only for patients on dialysis. Therefore a key question for the panel was to decide whether safety issues in the non-dialysis population would also show up in dialysis patients, or whether the two populations were too different.