FDA Approves Advate to Treat Hemophilia A

The U.S. Food and Drug Administration (FDA) approved Baxter International Inc.’s Advate (antihemophilic factor [recombinant] plasma/ albumin free method) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A. Advate is the only antihemophilic factor approved in the U.S. for prophylactic use in both adults and children.

The approval is based on a Phase IV prophylaxis study, which demonstrated a statistically significant reduction in the median annual bleeding rate. Patients receiving on-demand treatment experienced 44 bleeds (per patient per year) compared with one bleed (per patient per year) while on either of the prophylactic regimens evaluated (a 98-percent reduction in annual bleed rate). Forty-two percent of study patients experienced zero bleeds during one year on prophylaxis. And, of the two prophylactic regimens approved for use, the dosing schedule of every three days (a pharmacokinetic-driven regimen based on patients’ clinical response) offered some patients the option of fewer infusions over one year of treatment.