Lojuxta (lomitapide)
- Region
- 🇪🇺 EU
- Active substance
- lomitapide
- Company
- Chiesi Farmaceutici SpA
- Status
- Authorised
- Therapeutic area
- Hypercholesterolemia
- CHMP opinion
- Thu 30 May 2013
- EU approval
- Wed 31 Jul 2013
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/002578
- ATC
- C10AX12
- Official record
- www.ema.europa.eu
Indication
Lojuxta is indicated as an 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 hyperlipoproteinaemia and secondary causes of hypercholesterolaemia (e.g. nephrotic syndrome, hypothyroidism) must be excluded.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.