In late April, Emergent BioSolutions, Inc., announced that the US Food and Drug Administration (FDA) has approved IXINITY®, the company’s recombinant factor IX (rFIX) product. IXINITY® is indicated for the control and prevention of bleeding episodes and for perioperative management in adults and children, 12 years of age or older, with hemophilia B.
The FDA approval is based on results from global, multicenter Phase I/III clinical studies evaluating safety, efficacy and pharmacokinetics in previously treated adults and children 12 years of age or older with severe to moderately severe hemophilia B.
One or two infusions of IXINITY® resolved 84% of the bleeds subjects experienced. The patients rated that response as “excellent” or “good." Excellent was defined as a dramatic response with abrupt pain relief and clear reduction in joint or hemorrhage site size. Good was defined as pain relief or reduction in hemorrhage site size, but that may have required an additional infusion for resolution. In addition, the pharmacokinetic results (the absorption, distribution, metabolism and excretion of a drug) showed that IXINITY® achieved similar behavior to another licensed recombinant coagulation factor IX product on the market.
“I am very excited about the approval of IXINITY and give my congratulations to Emergent for reaching this wonderful milestone ,” said John Taylor, founder of the Coalition for Hemophilia B. He is also co-founder of Inspiration Biopharmaceuticals, which began development of IXINITY prior to the product being acquired by Emergent through its acquisition of Cangene Corporation. “Our goal for IXINITY was to offer choice to a wider group of patients than ever before and I am proud that Emergent has continued this work.”
Source: Emergent BioSolutions press release dated April 30, 2015
