Peginesatide regulatory update
FDA's Oncologic Drugs Advisory Committee voted 15-1 with 1 abstention that Affymax's peginesatide has a favorable benefit-risk profile to treat anemia in patients with chronic kidney disease who are on dialysis. The panel agreed that Affymax demonstrated peginesatide's non-inferiority to standard of care epoetin alfa for efficacy and safety in dialysis patients in the Phase III EMERALD 1 and 2 trials. Panel members were concerned by the increased rate of cardiovascular events associated with peginesatide in the Phase III PEARL 1 and 2 trials in non-dialysis patients; however, they did not believe the results were comparable across populations due to differences in trial designs and patient characteristics.
One of the panel's 2 cardiologists voted against peginesatide while the other abstained. Both felt that the unblinded nature of the 4 trials made it too difficult to assess the overall benefits and risks of the once-monthly synthetic peptide-based erythropoiesis-stimulating agent (ESA). Affymax is seeking approval only in CKD patients on dialysis and has proposed to restrict distribution to only dialysis clinics. ...