Factor IX polypeptide formulations
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Publication Number
US-11642398-B2
Publication Date
2023-05-09
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 (rFIXFc) formulations containing sucrose, mannitol, sodium chloride, L-histidine, and polysorbate 20 or 80. It also describes lyophilized single-use kits for intravenous reconstitution. The rFIXFc polypeptide comprises human Factor IX fused to an Fc domain of a human antibody and has long-acting Factor IX activity.
The described methods use the formulation for hemophilia B prophylaxis, treatment of minor to moderate bleeding episodes, and surgical prophylaxis. The supplied partial content reports reductions in annualized bleeding rate for weekly and individualized-interval prophylaxis, and a longer terminal half-life than BeneFIX. The background section is not included in the supplied content, so the problem being solved is not explicitly described.
Claims Coverage
The relevant claims identify four independent claims covering prophylactic administration, treatment of bleeding episodes, surgical prophylaxis, and reduction of annualized bleeding rate using rFIXFc pharmaceutical compositions, providing four inventive features.
Prophylactic administration for hemophilia B
Intravenous administration of an rFIXFc composition containing sucrose, mannitol, sodium chloride, L-histidine, and polysorbate 20 or 80 to a hemophilia B subject in need of prophylaxis, wherein administration reduces the frequency of bleeding episodes.
Treatment of a bleeding episode
Intravenous administration of the rFIXFc composition to a hemophilia B subject in need of treatment of a minor to moderate bleeding episode, to control, alleviate, or reverse the episode.
Surgical prophylaxis
Intravenous administration of the rFIXFc composition to a hemophilia B subject in need of surgical prophylaxis, to control bleeding during and after surgery.
Reduction of annualized bleeding rate
Prophylactic administration of fixed or individualized doses of the rFIXFc composition at regular or individualized dosing intervals to reduce a hemophilia B subject's annualized bleeding rate.
The four independent claims establish coverage for hemophilia B prophylaxis, acute bleeding episode management, perioperative surgical control, and annualized bleeding rate reduction using the specified rFIXFc formulations.
Stated Advantages
The administration reduces the frequency of bleeding episodes in hemophilia B subjects.
Clinical results report reductions in annualized bleeding rate of 83% with weekly prophylaxis and 87% with individualized-interval prophylaxis.
The terminal half-life is reported to be approximately 2.4 times longer than that of BeneFIX.
The formulation is provided in a lyophilized single-use kit for intravenous reconstitution.
Documented Applications
Prophylaxis in subjects with hemophilia B.
Treatment of minor to moderate bleeding episodes in subjects with hemophilia B.
Surgical prophylaxis to control bleeding during and after surgery in subjects with hemophilia B.
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