CSL Behring has commenced the global Phase II/III, multi-centre study to assess the safety, efficacy and pharmacokinetics of recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP).
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rIX-FP is indicated for the prophylaxis and treatment of bleeding episodes in patients with congenital Factor IX (FIX) deficiency.
CSL Behring Global Clinical R&D senior vice president Russell Basser said the therapy using recombinant fusion protein linking coagulation factor IX with recombinant albumin can mean fewer injections for patients, and may enable or enhance prophylactic treatment, improving quality of life for patients.
"The unmet medical need is great for a factor IX product with an extended half-life for use in treating people with hemophilia B, a life-long, debilitating clotting disorder," Basser added.
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