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lomitapide (Lojuxta®)

 

Following non-submission

AWMSG advice

Status: Not endorsed (Statement of Advice)

In the absence of a submission from the holder of the marketing authorisation, lomitapide (Lojuxta®) cannot be endorsed for use within NHS Wales in adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH). Genetic confirmation of HoFH should be obtained whenever possible. Other forms of primary hyperlipoproteinemia and secondary causes of hypercholesterolemia (e.g., nephrotic syndrome, hypothyroidism) must be excluded.

 Statement of Advice (SOA): lomitapide (Lojuxta) 1182 (PDF, 179Kb)

Medicine details

Medicine name lomitapide (Lojuxta®)
Formulation 5 mg, 10 mg and 20 mg capsule
Reference number 1182
Indication

In adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH). Genetic confirmation of HoFH should be obtained whenever possible. Other forms of primary hyperlipoproteinemia and secondary causes of hypercholesterolemia (e.g., nephrotic syndrome, hypothyroidism) must be excluded

Company Aegerion Pharmaceuticals Ltd
BNF chapter Cardiovascular system
Submission type Non-submission
Status Not endorsed (Statement of Advice)
Date of issue 06/12/2013
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