Pharmaceutical compositions comprising human antibodies to PCSK9
First Claim
1. A unit dosage form of a pharmaceutical composition for single administration comprising a fixed dose of, 75 mg, 150 mg, or 300 mg of an antibody or an antigen-binding fragment thereof which specifically binds human proprotein convertase subtilisin/kexin type 9 (hPCSK9) together with a pharmaceutically acceptable excipient or carrier in a hermetically sealed container, wherein the antibody or antigen-binding fragment thereof comprises the three heavy chain CDRs set forth in SEQ ID NOs:
- 76, 78, and 80 and the three light chain CDRs set forth in SEQ ID NOs;
84, 86, and 88.
3 Assignments
0 Petitions
Accused Products
Abstract
The present invention relates to Pharmaceutical compositions comprising an antibody specifically binding to human proprotein convertase subtilisin/kexin type 9 (PCSK9), to methods for treating diseases or conditions in which proprotein convertase subtilisin/kexin type 9 (PCSK9) expression or activity causes an impact by administration of PCSK9-specific antibodies or antigen-binding fragments thereof and preferably by additional administration of an inhibitor of 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase). The present invention further relates to PCSK9-specific antibodies or antigen-binding fragments thereof for use in the treatment of diseases or conditions in which PCSK9 expression or activity causes an impact.
The present invention also relates to articles of manufacture comprising packaging material, PCSK9-specific antibodies or antigen-binding fragments thereof, and a label or packaging insert indicating which groups of patients can be treated with said antibodies or fragments, which groups of patients must not be treated with said antibodies or fragments, and which dosage regimen should be used.
The present invention further relates to methods of testing the efficacy of PCSK9-specific antibodies or antigen-binding fragments thereof for the treatment of certain diseases or conditions and for the treatment of specific sub-groups of patients.
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Citations
15 Claims
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1. A unit dosage form of a pharmaceutical composition for single administration comprising a fixed dose of, 75 mg, 150 mg, or 300 mg of an antibody or an antigen-binding fragment thereof which specifically binds human proprotein convertase subtilisin/kexin type 9 (hPCSK9) together with a pharmaceutically acceptable excipient or carrier in a hermetically sealed container, wherein the antibody or antigen-binding fragment thereof comprises the three heavy chain CDRs set forth in SEQ ID NOs:
- 76, 78, and 80 and the three light chain CDRs set forth in SEQ ID NOs;
84, 86, and 88. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- 76, 78, and 80 and the three light chain CDRs set forth in SEQ ID NOs;
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13. A unit dosage form of a pharmaceutical composition for single administration comprising a fixed dose of 75 mg of an antibody or an antigen-binding fragment thereof which specifically binds hPCSK9 together with a pharmaceutically acceptable excipient or carrier in a hermetically sealed container, wherein the antibody or antigen-binding fragment thereof comprises the heavy chain variable region (HCVR) amino acid sequence and the light chain variable region (LCVR) amino acid sequence set forth in SEQ ID NOs:
- 90 and 92, respectively, and wherein the antibody or antigen-binding fragment thereof is in a 1 ml injection solution.
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14. A unit dosage form of a pharmaceutical composition for single administration comprising a fixed dose of 150 mg of an antibody or an antigen-binding fragment thereof which specifically binds hPCSK9 together with a pharmaceutically acceptable excipient or carrier in a hermetically sealed container, wherein the antibody or antigen-binding fragment thereof comprises the heavy chain variable region (HCVR) amino acid sequence and the light chain variable region (LCVR) amino acid sequence set forth in SEQ ID NOs:
- 90 and 92, respectively, and wherein the antibody or antigen-binding fragment thereof is in a 1 ml injection solution.
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15. A unit dosage form of a pharmaceutical composition for a single administration comprising a fixed dose of 300 mg of an antibody or an antigen-binding fragment thereof which specifically binds hPCSK9 together with a pharmaceutically acceptable excipient or carrier in a hermetically sealed container, wherein the antibody or antigen-binding fragment thereof comprises the heavy chain variable region (HCVR) amino acid sequence and the light chain variable region (LCVR) amino acid sequence set forth in SEQ ID NOs:
- 90 and 92, respectively, and wherein the antibody or antigen-binding fragment thereof is in a 1 ml injection solution.
Specification