Recaticimab in primary hypercholesterolaemia and mixed dyslipidaemia: a profile of its use

Recaticimab (艾心安), a humanised immunoglobulin G1 monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), expands the treatment options available for adults with primary hypercholesterolaemia and mixed dyslipidaemia when used in combination with statins (with or without other lipid-lowering therapies), while also providing an important monotherapy option for patients. It is the only anti-PCSK9 monoclonal antibody approved for use as monotherapy in China. In the phase 3 REMAIN trials in adults with hypercholesterolaemia and mixed dyslipidaemia, subcutaneous recaticimab 150 mg once every 4 weeks and recaticimab 300 mg once every 8 weeks reduced plasma low-density lipoprotein cholesterol (LDL-C) compared with placebo, with benefits observed at week 12 to week 48 following treatment initiation. Based on pooled analysis, recaticimab was generally well tolerated, with mostly mild and transient injection site reactions being the most common adverse reaction. Hypercholesterolaemia and mixed dyslipidaemia are major risk factors for atherosclerotic cardiovascular disease. The primary aim of treatment of hypercholesterolaemia is to reduce plasma levels of LDL-C, which in turn correlates with a reduced risk of a major cardiovascular event. Recaticimab (艾心安) is a long-acting monoclonal antibody against PCSK9 and is approved in China for the treatment of primary hypercholesterolaemia and mixed dyslipidaemia as monotherapy and in combination with statins (with or without other lipid-lowering therapies). When administered by injection under the skin once every 4–8 weeks, recaticimab reduced LDL-C in adults with hypercholesterolaemia and mixed dyslipidaemia in phase 3 clinical trials. Recaticimab was generally well tolerated, with the most common adverse drug reactions being injection site reactions, which occurred more frequently than with placebo, and abnormal liver enzymes, which were observed at rates comparable to placebo. Recaticimab expands the treatment options for adults with primary hypercholesterolaemia and mixed dyslipidaemia when used in combination with statins (with or without other lipid-lowering therapies), while also providing an important monotherapy option for patients.