NILEMDO (bempedoic acid) - Dyslipidaemia

The Committee deems that the clinical benefit of NILEMDO (bempedoic acid) 180 mg film-coated tablets is substantial only in adults at high or very high cardiovascular risk, who are statin-intolerant, or for whom a statin is contraindicated, to reduce cardiovascular risk by lowering LDL-c levels when goals have not been achieved despite optimised lipid-lowering treatment:

• in the event of high risk of atherosclerotic cardiovascular disease (primary prevention);
• or in the event of established atherosclerotic cardiovascular disease (secondary prevention).

Considering:

• evidence of the superiority of NILEMDO (bempedoic acid) compared to placebo in terms of the reduction in the risk of occurrence of major cardiovascular events (MACE-4 and MACE-3) in subjects who are statin-intolerant and have established atherosclerotic cardiovascular disease or are at high risk of atherosclerotic cardiovascular disease (Clear-OUTCOMES study);
• the favourable safety profile of bempedoic acid;
• the currently partially met medical need;

but in view of:

• uncertainty with respect to the overall clinical effect of bempedoic acid on cardiovascular mortality and given the absence of evidence of a statistically significant difference versus placebo on the reduction of stroke, cardiovascular death and all-cause death;
• the absence of a comparison versus an active comparator, despite this being feasible, particularly in part of the primary prevention population;
• the absence of treatment compliance and quality of life data;

the Committee deems that NILEMDO (bempedoic acid) 180 mg film-coated tablets provides no clinical added value (CAV V) in the current care pathway for the management of adults in the event of high risk of atherosclerotic cardiovascular disease (primary prevention) or in the event of established atherosclerotic cardiovascular disease (secondary prevention).

In the other clinical situations covered by the MA indication: not applicable.