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AssigneeBioverativ Therapeutics Inc.
InventorsJennifer A. Dumont, Susan Low, Alan J. Bitonti, Glenn Pierce, Alvin Luk, Haiyan Jiang, Byron McKinney, Matt Ottmer, Jurg Sommer, Karen Nugent, Lian Li, Robert T. Peters
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The present invention provides methods of administering Factor VIII (processed FVIII, single chain FVIII, or a combination thereof); methods of administering chimeric and hybrid polypeptides comprising Factor VIII; chimeric and hybrid polypeptides comprising Factor VIII; polynucleotides encoding such chimeric and hybrid polypeptides; cells comprising such polynucleotides; and methods of producing such chimeric and hybrid polypeptides using such cells.
A method of treating hemophilia A in a subject in need thereof, comprising administering to the subject an effective amount of a pharmaceutical composition comprising (i) a chimeric polypeptide, which comprises Factor VIII (FVIII) and a second portion, and (ii) at least one pharmaceutically acceptable excipient, wherein 15% to 40% of the FVIII of the chimeric polypeptide is single chain FVIII and 60% to 85% of the FVIII of the chimeric polypeptide is processed FVIII, wherein the single chain FVIII comprises a FVIII heavy chain and a FVIII light chain on a single polypeptide chain and the processed FVIII comprises a FVIII heavy chain and a FVIII light chain on two polypeptide chains.
A method of decreasing the incidence of spontaneous bleeding in a subject who has hemophilia A, comprising administering to the subject an effective amount of a pharmaceutical composition comprising (i) a FVIIIFc monomer dimer hybrid comprising a single molecule of recombinant B-domain deleted human FVIII (BDD-rFVIII) fused to the N-terminus of a polypeptide of a dimeric human IgG1 Fc domain with no intervening linker sequence, and (ii) at least one pharmaceutically acceptable excipient,
Dependencies are inferred from the claim text.