Baxter Advate approval
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Baxter's clotting factor Advate (recombinant antihemophilic factor plasma/albumin-free [rAHF-PFM]) clears FDA July 25 for treatment of hemophilia A. Advate is the only factor VIII manufactured without human or animal plasma proteins, "thereby eliminating the risk of infections caused by viruses that may be carried in these proteins." The firm is touting the product's purity and "greater convenience based on its higher potency and lower infusion volume" compared to its previous rAHF product,Recombinate. Advate will be priced slightly higher than Recombinate when it begins shipping in the next few weeks, Baxter says