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US 12,565,526 B2Granted
Formulations of anti-RSV antibodies and methods of use thereof
AssigneeMerck Sharpe & Dohme Ltd.
InventorsVenus Hashemi, Arnab De, Chakravarthy Nachu Narasimhan
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Abstract
The present invention relates to stable formulations comprising antibodies or antigen-binding fragments thereof that bind to respiratory syncytial virus (RSV). Also provided are methods of preventing and/or treating RSV-related diseases with the formulations of the invention.
Claims17
An anti-RSV antibody formulation comprising:
- a) about 50 mg/mL to about 250 mg/mL of an anti-RSV antibody, or antigen-binding fragment thereof,
- wherein the anti-RSV antibody, or antigen-binding fragment thereof, comprises a heavy chain variable region having the amino acid sequence of SEQ ID NO:
- 7 and a light chain variable region having the amino acid sequence of SEQ ID NO:
- 8;
- b) about 5 mM to about 20 mM histidine;
- c) about 4% to about 8% (w/v) sucrose;
- d) about 70 mM of L-arginine or a pharmaceutically acceptable salt of L-arginine;
- and
- e) about 0.01% to about 0.10% (w/v) polysorbate 80, and
- wherein the formulation is free of L-glutamate.
7 more elements
An anti-RSV antibody formulation consisting of:
- a) about 125 mg/mL to about 175 mg/mL of an anti-RSV antibody
- wherein the anti-RSV antibody comprises a heavy chain variable region having the amino acid sequence of SEQ ID NO:
- 7 and a light chain variable region having the amino acid sequence of SEQ ID NO:
- 8;
- b) about 10 mM histidine;
- c) about 4% to about 8% (w/v) sucrose;
- d) about 70 mM of L-arginine or a pharmaceutically acceptable salt of L-arginine;
- and
- e) about 0.02% (w/v) polysorbate 80.
6 more elements
Dependencies are inferred from the claim text.