Rixubis: Phase II/III data

An open-label, international Phase II/III trial in 23 previously treated patients aged <12 years with severe or moderately severe hemophilia B showed that twice-weekly prophylactic Rixubis at a median dose of 56 IU/kg for 6 months led to a median annualized bleeding rate of 2.0, with 9 patients experiencing no bleeds. Additionally, hemostatic efficacy of Rixubis was rated as "good" or "excellent" at resolving bleeds in 96% of all episodes. Furthermore, the majority of bleeds were resolved after 1-2 infusions. Rixubis was well tolerated with no reports of inhibitor development, allergic reactions or thrombotic or treatment-related adverse events. Baxter said it submitted the data as part of a regulatory application to FDA for Rixubis to treat hemophilia B in pediatric patients. Data were presented at the American Society of Hematology meeting in New Orleans. ...