Baxter International, Inc., recently announced its submission of a biologics license application (BLA) supplement to the US Food and Drug Administration (FDA) for the approval of prophylactic treatment of FEIBA NF in patients with hemophilia A or B and inhibitors. FEIBA NF is Baxter’s plasma-derived activated prothrombin complex concentrate (aPCC) for use in patients with inhibitors to infused factor VIII or IX. aPCCs are known as bypassing agents because they bypass the need for the deficient clotting factor proteins (VIII or IX) in the clotting cascade. An estimated 1/3 of people with hemophilia A or B develop inhibitors, or antibodies, to infused factor product.
The application was based on a recently completed Phase III study that was designed to measure the efficacy and safety of routine prophylaxis compared to on-demand treatment of FEIBA NF in patients with hemophilia A or B and inhibitors. Results showed a reduced median annual bleed rate from 28.7 bleeds during FEIBA NF on-demand treatment to 7.9 during FEIBA NF prophylactic treatment, representing a 72.5% reduction. Further, the study showed that 17% of the patients had no joint bleeds.
“This regulatory submission helps fulfill Baxter's commitment to advancing care for patients who have developed inhibitors, a serious and sometimes life-threatening complication for those with hemophilia A or B,” said Professor Hartmut J. Ehrlich, MD, vice president of global research and development in Baxter's BioScience business. “Baxter has been supporting innovations in care for the hemophilia community for more than 60 years, and our work continues not only with FEIBA NF, but also with other treatments we are actively developing.”
Source: Baxter press release dated February 26, 2013