Anti-α4β7 antibody articles of manufacture
AssigneeTakeda Pharmaceutical Company Limited
InventorsIrving H. Fox, Catherine Scholz, Erica Helen Jenkins, Maria Rosario
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Abstract
Antibody formulations are described comprising a mixture of an anti-α4β7 antibody, an antioxidant or chelator, and at least one free amino acid. The disclosed formulations may have improved stability, reduced aggregate formation, or both. The present invention further provides a safe dosing regimen of these antibody formulations that is easy to follow, and which results in a therapeutically effective amount of the anti-α4β7 antibody in vivo.
Claims16
A prefilled syringe comprising a liquid pharmaceutical formulation of 108 mg of a humanized anti-α4β7 antibody, wherein the humanized anti-α4β7 antibody comprises a light chain comprising SEQ ID NO:
- 11 (LCDR1), SEQ ID NO:
- 12 (LCDR2), and SEQ ID NO:
- 13 (LCDR3), and a heavy chain comprising SEQ ID NO:
- 8 (HCDR1), SEQ ID NO:
- 9 (HCDR2), and SEQ ID NO:
- 10 (HCDR3), wherein the humanized anti-α4β7 antibody does not bind to αEβ7, and wherein the prefilled syringe is for subcutaneous administration, has an injection volume of 0.5 mL to 2 mL, and comprises a single dose of the humanized anti-α4β7 antibody.
An article of manufacture for treating ulcerative colitis comprising:
- a prefilled syringe for subcutaneous administration, containing a liquid pharmaceutical formulation comprising 108 mg of a humanized anti-α4β7 antibody, wherein the prefilled syringe has an injection volume of 0.5 mL to 2 mL, wherein the humanized anti-α4β7 antibody comprises a light chain comprising SEQ ID NO:
- 11 (LCDR1), SEQ ID NO:
- 12 (LCDR2), and SEQ ID NO:
- 13 (LCDR3), and a heavy chain comprising SEQ ID NO:
- 8 (HCDR1), SEQ ID NO:
- 9 (HCDR2), and SEQ ID NO:
- 10 (HCDR3), and wherein the humanized anti-α4β7 antibody does not bind to αEβ7;
- and
- instructions for self-administration of the formulation according to a dosing regimen for treating ulcerative colitis.
An autoinjector comprising a liquid pharmaceutical formulation of 108 mg of a humanized anti-α4β7 antibody, wherein the humanized anti-α4β7 antibody comprises a light chain comprising SEQ ID NO:
- 11 (LCDR1), SEQ ID NO:
- 12 (LCDR2), and SEQ ID NO:
- 13 (LCDR3), and a heavy chain comprising SEQ ID NO:
- 8 (HCDR1), SEQ ID NO:
- 9 (HCDR2), and SEQ ID NO:
- 10 (HCDR3), wherein the humanized anti-α4β7 antibody does not bind to αEβ7, and wherein the autoinjector is for subcutaneous administration, has a prefilled syringe with an injection volume of 0.5 mL to 2 mL, and comprises a single dose of the humanized anti-α4β7 antibody.
An article of manufacture for treating ulcerative colitis comprising:
- an autoinjector for subcutaneous administration, containing a liquid pharmaceutical formulation comprising 108 mg of a humanized anti-α4β7 antibody, wherein the autoinjector has prefilled syringe with an injection volume of 0.5 mL to 2 mL, wherein the humanized anti-α4β7 antibody comprises a light chain comprising SEQ ID NO:
- 11 (LCDR1), SEQ ID NO:
- 12 (LCDR2), and SEQ ID NO:
- 13 (LCDR3), and a heavy chain comprising SEQ ID NO:
- 8 (HCDR1), SEQ ID NO:
- 9 (HCDR2), and SEQ ID NO:
- 10 (HCDR3), and wherein the humanized anti-α4β7 antibody does not bind to αEβ7;
- and
- instructions for self-administration of the formulation according to a dosing regimen for treating ulcerative colitis.
Dependencies are inferred from the claim text.