METHODS OF TREATING PATIENTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH) Russian patent published in 2020 - IPC A61K39/00 A61K39/395 A61P9/10 

FIELD: medicine.

SUBSTANCE: group of inventions relates to the treatment of hypercholesterolemia. Method of treating involves selecting a patient with heterozygous familial hypercholesterinemia (heFH) are not adequately controlled by to the maximally tolerable statin therapy; administering to a patient an antibody or antigen-binding fragment thereof, which specifically binds human PCSK9, wherein the antibody or its antigen-binding fragment comprises the heavy and light chain CDR amino acid sequences having SEQ ID NO: 2, 3, 4, 7, 8 and 10, where introduction of the antibody or its antigen-binding fragment includes: (i) administering two or more initial doses of 75 mg, an antibody or an antigen-binding fragment thereof every two weeks; and (ii) administering one or more additional doses of 75 mg, an antibody or an antigen-binding fragment thereof every two weeks if the patient's LDL-C level after step (i) <70 mg/dl, or administering to a subject one or more doses of 150 mg, an antibody or an antigen-binding fragment thereof every two weeks if the LDL-C level in the patient after step (i) ≥70 mg/dL. Also disclosed is another version of treating hypercholesterolemia in a patient.

EFFECT: group of inventions provides treating hypercholesterolaemia, which is resistant to statin therapy.

13 cl, 37 tbl, 5 ex, 14 dwg