Baxter International Inc,. recently announced that the US. Food and Drug Administration (FDA) has approved a new 4,000 IU dosage strength of ADVATE, the company’s recombinant factor VIII product. ADVATE is indicated for the control and prevention of bleeding episodes in patients with hemophilia A.
According to a Baxter news release, the new 4,000 IU dosage strength provides the convenience of single vial dosing for many adult patients. “The 4,000 IU dose is particularly well-suited for patients on an every three-day prophylaxis regimen,” said Bruce Ewenstein, MD, PhD, vice president, clinical affairs, Baxter's BioScience business.
In December 2011, ADVATE was approved by the US FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A. It is the only antihemophilic recombinant FVIII treatment approved in the US for prophylactic use in both adults and children up to 16 years old. The approval was based on phase IV data showing that routine prophylaxis of ADVATE significantly reduced median annual bleed rates (ABR) in hemophilia A patients from 44 to 1, compared to an on-demand regimen, a 98% reduction in ABR. While on one year of prophylactic treatment, 42% of patients experienced no bleeding episodes.
Source: Baxter news release dated July 16, 2012