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Bempedoic acid for treating primary hypercholesterolaemia or mixed dyslipidaemia

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2 Information about bempedoic acid

Marketing authorisation indication

Bempedoic acid

2.1 Bempedoic acid (Nilemdo, Daiichi Sankyo) is 'indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

  • in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or

  • alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated'.

Bempedoic acid–ezetimibe

2.2 Bempedoic acid–ezetimibe (Nustendi, Daiichi Sankyo) is 'indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

  • in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe or

  • 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,

  • in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin'.

Dosage in the marketing authorisation

2.3 The dosage schedule for bempedoic acid is available in the summary of product characteristics.

2.4 The dosage schedule for bempedoic acid–ezetimibe is available in the summary of product characteristics

Price

2.5 Bempedoic acid and bempedoic acid–ezetimibe costs £55.44 per 28-pack, excluding VAT.