Human antibodies to pcsk9 for use in methods of treating particular groups of subjects

A subject and antibody technology, applied in the treatment of diseases or conditions affected by PCSK9 expression or activity, in the treatment of specific patient subgroups, in the field of PCSK9-specific antibodies or antigen-binding fragments, can solve the problem of low target achievement rate

Inactive Publication Date: 2013-12-25
SANOFI BIOTECH
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  • Claims
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Problems solved by technology

Furthermore, since the most effective lipid-lowering agents can only lower LDL-C levels by up to 55%, target achievement rates in patients requiring substantial LDL-C lowering, such as those with familial hypercholesterolemia (target attainment rate) is often significantly lower than can be expected

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  • Human antibodies to pcsk9 for use in methods of treating particular groups of subjects
  • Human antibodies to pcsk9 for use in methods of treating particular groups of subjects
  • Human antibodies to pcsk9 for use in methods of treating particular groups of subjects

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[0168] The present invention will now be further described. The different aspects of the invention are defined in more detail in the following paragraphs. Each aspect so defined may be combined with any other aspect or aspects unless clearly indicated to the contrary. In particular, any feature indicated as being preferred or advantageous may be combined with any other feature or features indicated as being preferred or advantageous unless clearly indicated to the contrary.

[0169] In a first aspect, the present invention relates to a method for treating a disease or condition affected by expression or activity of PCSK9, comprising:

[0170] Administering a therapeutic amount of an antibody or antigen-binding fragment thereof that specifically binds to hPCSK9 (human proprotein convertase subtilisin / kexin type 9) to a subject in need thereof, wherein the administered dose ranges from 5 mg to 500 mg said antibody or antigen-binding fragment thereof, and

[0171] The subject ...

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Abstract

The present invention relates 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.

Description

[0001] The present invention relates to a method for treating diseases or conditions affected by the expression or activity of proprotein convertase subtilisin / kexin type 9 (proprotein convertase subtilisin / kexin type 9, PCSK9) by administering a PCSK9 specific antibody or an antigen binding thereof Fragmentation, and preferably, by additional administration of a 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase) inhibitor. The invention further relates to PCSK9-specific antibodies or antigen-binding fragments thereof, preferably in combination with an HMG-CoA reductase inhibitor, for use in the treatment of diseases or conditions in which PCSK9 expression or activity is affected. [0002] The invention also relates to an article of manufacture comprising packaging material, a PCSK9-specific antibody or antigen-binding fragment thereof, and a label or package insert indicating which groups of patients may be treated with the antibody or fragment and which groups of pat...

Claims

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Application Information

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IPC IPC(8): C07K16/40
CPCC07K16/40G01N33/92C07K2317/76C07K2317/21G01N2800/044A61K2039/505A61K31/215A61K31/366A61K31/404A61K31/435A61K31/47A61K31/505A61P3/00A61P3/06A61P43/00A61P5/00A61P7/00A61P9/00A61P9/10A61J1/05A61K39/3955A61K39/395C07K14/4703A61K45/06A61K2039/545A61K39/00
Inventor C.哈诺廷L.贝萨克U.乔哈里
Owner SANOFI BIOTECH
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