US 2014/0154262 A1 · HUMAN ANTIBODIES TO PCSK9 FOR USE IN METHODS OF TREATING PARTICULAR GROUPS OF SUBJECTS

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.

Claims21

Dependent claims

A method for treating a disease or condition in which proprotein convertase subtilisin/kexin type 9 (PCSK9) expression or activity causes an impact, comprising:

(a) administering a therapeutic amount of an antibody or an antigen-binding fragment thereof which specifically binds PCSK9 to a subject in need thereof, wherein the antibody or antigen-binding fragment thereof is administered in a dosage amount ranging from about 40 mg to 500 mg, and
(b) administering a therapeutic amount of an HMG-CoA reductase inhibitor to said subject, wherein the HMG-CoA reductase inhibitor is preferably administered in a dosage amount ranging from 0.05 mg to 100 mg.

A method for treating a disease or condition in which PCSK9 expression or activity causes an impact comprising administering a therapeutic amount of an antibody or an antigen-binding fragment thereof which specifically binds PCSK9 to a subject in need thereof, wherein the subject in need thereof falls into one or more of the following groups of subjects:

(i) subjects having a serum LDL cholesterol (LDL-C) level of at least 100 mg/dL,
(ii) subjects having a serum HDL-C level of less than 40 mg/dL;
(iii) subjects having a serum cholesterol level of at least 200 mg/dL;
(iv) subjects having a serum triacylglycerol level of at least 150 mg/dL, wherein said triacylglycerol level is determined after fasting for at least 8 hours;
(v) subjects being at least 35 years old;
(vi) subjects younger than 75 years old;
(vii) subjects having a BMI of 25 or more;
(vii) subjects in which the administration of said antibody or antigen-binding fragment thereof leads to a reduction in the serum LDL-C level by at least 30 mg/dL relative to predose level;
and
(viii) subjects in which the administration of said antibody or antigen-binding fragment thereof leads to a reduction in the serum LDL-C level by at least 20% relative to predose level.

7 more elements

Dependencies are inferred from the claim text.

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

Life of this patent

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

Life of this patent

Abstract

Claims21