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OCTA101 is a subcutaneously administered recombinant factor VIII (rFVIII) therapy developed for the prophylactic treatment of severe hemophilia A. It consists of a recombinant FVIII molecule fused with a recombinant von Willebrand factor fragment dimer. The drug was designed to offer an alternative to intravenous FVIII by enabling subcutaneous administration, potentially improving convenience and adherence for patients. In clinical studies, OCTA101 demonstrated a 2.5-fold longer terminal half-life compared to intravenous rFVIII and had a bioavailability of 16.6%. Efficacy data indicated that daily prophylaxis with 40–60 IU/kg was effective in managing hemophilia A in the absence of FVIII inhibitors. However, the development of inhibitors (antibodies against FVIII) in some patients led to early termination of clinical trials[1][2][5].
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