Factor IX polypeptide formulations
Inventors
Assignees
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Publication Number
US-12653871-B2
Publication Date
2026-06-16
Expiration Date
Abstract
The present invention provides formulations comprising a Factor IX—FcRn Binding Partner (FIXFBP) polypeptide, and methods of administering FIXFBP.
Core Innovation
The invention describes long-acting recombinant Factor IX-Fc formulations containing sucrose, mannitol, sodium chloride, L-histidine, and polysorbate 20 or polysorbate 80. It presents the formulation as a lyophilized pharmaceutical kit with a separate diluent container, and also as a composition in a vial or syringe. The supplied claim text defines these product forms and their constituent ingredients.
The supplied partial content does not include the background section, so the problem described there is not explicitly available. The summary reports an approximately 82-hour terminal half-life, reduced annualized bleeding rates with prophylaxis, control of most bleeding episodes with one injection, and good or excellent hemostasis in assessed major surgeries. These reported results relate to the FIX-Fc formulation described in the document.
Claims Coverage
The claims cover three inventive features across three independent claims covering a pharmaceutical kit, a vial, and a syringe.
Lyophilized pharmaceutical kit with diluent
A first container contains a lyophilizate comprising a Factor IX-Fc chimeric polypeptide, sucrose, mannitol, L-histidine, and polysorbate 20 or polysorbate 80. A second container contains a sodium chloride diluent for combining with the lyophilizate.
Vial containing a FIX-Fc composition
A vial contains a pharmaceutical composition comprising a Factor IX-Fc chimeric polypeptide, sucrose, mannitol, sodium chloride, L-histidine, and polysorbate 20 or polysorbate 80.
Syringe containing a FIX-Fc composition
A syringe contains a pharmaceutical composition comprising a Factor IX-Fc chimeric polypeptide, sucrose, mannitol, L-histidine, polysorbate 20 or polysorbate 80, and sodium chloride.
The three independent claims cover distinct presentations of the FIX-Fc formulation: a lyophilized kit with diluent, a vial, and a syringe.
Stated Advantages
The reported terminal half-life is approximately 82 hours, stated as 2.43 times that of BeneFIX.
Prophylaxis is associated with reduced annualized bleeding rates.
One injection controls 90.4% of reported bleeding episodes.
Excellent or good hemostasis is reported in all assessed major surgeries.
Documented Applications
The document reports prophylactic use in hemophilia B, with reduced annualized bleeding rates.
The document reports use for control of bleeding episodes, including control of 90.4% of episodes with one injection.
The document reports use in major surgeries, with excellent or good hemostasis in all assessed cases.
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