Pharmaceutical compositions comprising human antibodies to PCSK9

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.

Description

field of invention [0001] The present invention relates to a pharmaceutical composition comprising a proprotein convertase subtilisin / kexin type 9 (proprotein convertase subtilisin / kexin type 9, PCSK9) specific antibody or an antigen-binding fragment thereof, preferably, it comprises 3-hydroxy-3-formazan Inhibitors of HMG-glutaryl-CoA reductase (HMG-CoA reductase). The present invention further relates to injection solutions, dry formulations and unit dosage forms comprising PCSK9-specific antibodies or antigen-binding fragments thereof and their use for the treatment of diseases or conditions in which PCSK9 expression or activity is affected (preferably in combination with HMG-CoA reductase combination of inhibitors). [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, for example, which groups of patients may be treated with th...

AI Technical Summary

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

Images