Methods for treating patients with heterozygous familial hypercholesterolemia (heFH) with an anti-PCSK9 antibody

A method for reducing low density lipoprotein cholesterol (LDL-C) comprising:

• administering to a patient in need thereof one or more doses of 75 mg at a frequency of once every two weeks of an antibody or antigen-binding fragment thereof that specifically binds human proprotein convertase subtilisin/kexin type 9 (PCSK9), wherein the antibody or antigen-binding fragment thereof comprises a heavy chain variable region (HCVR) and a light chain variable region (LCVR) having the amino acid sequences of SEQ ID NOs:
• 1 and 6, respectively,
• wherein the patient has heterozygous familial hypercholesterolemia (heFH) that is inadequately controlled by a maximally tolerated dose of statin therapy, wherein prior to treatment the patient has a serum LDL-C concentration of greater than or equal to 100 mg/dL without a history of documented cardiovascular disease, and wherein:
• (a) the 75 mg dose is maintained if the patient's LDL-C measured after five or more doses is lower than 70 mg/dL;
• or
• (b) the 75 mg dose is discontinued if the patient's LDL-C measured after five or more doses is greater than or equal to 70 mg/dL, and the antibody or antigen-binding fragment thereof that specifically binds PCSK9 is subsequently administered to the patient at a dose of 150 mg at a frequency of once every two weeks.