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news.Baxter has submitted a biologics license application (BLA) supplement to the US Food and Drug Administration (FDA) for the approval of its prophylaxis treatment of FEIBA NF [Anti-Inhibitor Coagulant Complex], Nanofiltered and Vapor Heated, used in treating patients with hemophilia A or B and inhibitors.
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The firm recently released results from the pivotal Phase III study, which formed the basis for the BLA submission.
The study demonstrated that routine prophylactic treatment with FEIBA NF reduced median annual bleed rate (ABR) from 28.7 during FEIBA NF on-demand treatment compared to 7.9 during FEIBA NF prophylactic treatment (a 72.5% reduction), with 17% (3 of 17) of patients in the intent-to-treat group experiencing zero joint bleeds.
Baxter’s BioScience business global research and development vice president Prof. Hartmut Ehrlich said the firm’s regulatory submission helps fulfill the company’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.
"Baxter has been supporting innovations in care for the hemophilia community for more than 60 years, and our work continues not only with FEIBA, but also with other treatments we are actively developing," Ehrlich added.