Countdown to showdown

After a positive FDA panel vote and little push-back from the agency, Affymax Inc. looks well on its way to being the first company in 20 years to challenge Amgen Inc.'s dominance in the ESA dialysis space. Affymax is banking on the ease of use of its once-monthly peginesatide and the potential to reduce overall dialysis costs to compete with Amgen, which has already tied up almost one-third of the market with multi-year supply deals.

Last week, FDA's Oncologic Drugs Advisory Committee voted 15-1 with one abstention that peginesatide had a favorable benefit-risk profile to treat anemia in chronic kidney disease patients on dialysis...