EMA Panel Backs Bempedoic Acid Alone and With Ezetimibe

Megan Brooks

January 31, 2020

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of bempedoic acid (Nilemdo) and the fixed-dose combination of bempedoic acid/ezetimibe (Nustendi) to treat adults with primary hypercholesterolemia and mixed dyslipidemia.

Once approved in Europe, Nilemdo will be available as 180 mg film-coated tablets and Nustendi will be available as 180 mg/10 mg film-coated tablets. Both products are from FGK Representative Service GmbH.

Bempedoic acid reduces low-density-lipoprotein cholesterol (LDL-C) by inhibiting cholesterol synthesis in the liver, whereas ezetimibe reduces cholesterol absorption in the intestine.

Both bempedoic acid alone and with ezetimibe lower non-high-density-lipoprotein cholesterol (non-HDL-C), apolipoprotein B, and total cholesterol in adults with hypercholesterolemia or mixed dyslipidemia when administered alone and in combination with other lipid-modifying agents.

Bempedoic acid is indicated in adults with primary hypercholesterolemia (heterozygous familial and nonfamilial) or mixed dyslipidemia as an adjunct to diet in the following instances, according to an EMA statement: in combination with a statin or statin with other lipid-lowering therapies in patients who fail to reach LDL-C goals on maximum tolerated doses of a statin; and alone or in combination with other lipid-lowering therapies in patients who can't tolerate a statin or who have a contraindication to statin therapy.

Results of the CLEAR Wisdom and CLEAR Harmony trials demonstrated significant LDL-C lowering with bempedoic acid, as reported by theheart.org | Medscape Cardiology.

The fixed-dose combination of bempedoic acid and ezetimibe is indicated for adults with primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet in the following instances, according to an EMA statement: with a statin in patients who don't reach LDL-C goals on a maximum tolerated statin dose in addition to ezetimibe; alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone; and in patients already taking bempedoic acid and ezetimibe as separate tablets with or without statin, the EMA statement says.

A study presented last spring at the European Atherosclerosis Society 2019 Congress showed that the bempedoic acid/ezetimibe fixed-dose combination substantially lowered LDL-C levels, even in the presence of statins.

As reported by theheart.org | Medscape Cardiology, the study involved more than 300 patients, 65% of whom were already taking a statin at the maximally tolerated dose, randomized to the fixed-dose combination of bempedoic acid and ezetimibe, bempedoic acid alone, ezetimibe alone, or placebo.

Regardless of other lipid-lowering therapy, the fixed-dose combination lowered LDL-C levels by a significant 36%, or 38% when compared with placebo, versus 23% for ezetimibe alone and 17% for bempedoic acid.

Bempedoic acid for cholesterol-lowering in statin-intolerant patients made the Cleveland Clinic's list of top 10 medical innovations for 2020, although it has yet to be approved in the United States.

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