Human medicines European public assessment report (EPAR): Nilemdo, bempedoic acid, Date of authorisation: 01/04/2020, Revision: 7, Status: Authorised

Primary hypercholesterolaemia or mixed dyslipidaemia

Nilemdo effectively reduced LDL cholesterol levels in four main studies involving adults with hypercholesterolaemia or mixed dyslipidaemia, in which Nilemdo was compared with placebo (a dummy treatment).

Two of the studies involved a total of 3,009 patients who were also taking the maximum tolerated doses of statins with or without other fat-lowering medicines. After three months, patients taking Nilemdo had reductions in LDL cholesterol levels of 15% in one study and 17% in the other, while there was a rise in LDL cholesterol levels of around 2% in patients taking placebo in both studies.

The other two studies involved a total of 614 patients who were not able to take a statin or were only taking a low dose. After three months, LDL cholesterol levels in these studies were reduced by 23% and 24% in patients taking Nilemdo compared with a decrease of 1% and an increase of 5% respectively in patients taking placebo.

Atherosclerotic cardiovascular disease

Nilemdo was studied in almost 14,000 adults who were intolerant to statins and who had or were at high risk for cardiovascular disease. After at least 2 years of treatment, 11.7% (819 out of 6,992) of patients given Nilemdo experienced a cardiovascular event (meaning death, heart attack, stroke, or surgery to restore blood flow to the heart), compared with 13.3% (927 out of 6,978) of patients given placebo.