Lojuxta - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

lomitapide

Opinion

On 26 March 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Lojuxta. The marketing authorisation holder for this medicinal product is Chiesi Farmaceutici S.p.A.

The CHMP adopted a change to the existing indication as follows:

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 for the treatment of in adult and paediatric patients aged 5 years and older patients with homozygous familial hypercholesterolaemia (HoFH).

Genetic confirmation of HoFH should be obtained whenever possible. Other forms of primary hyperlipoproteinemia and secondary causes of hypercholesterolaemia (e.g. nephrotic syndrome, hypothyroidism) must be excluded.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Notes: New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Lojuxta (X/0000258068)

Adopted Reference Number: EMADOC-1700519818-3013044

Key facts

• Name of medicine:
  Lojuxta
• EMA product number:
  EMEA/H/C/002578
• Active substance:
  Lomitapide
• International non-proprietary name (INN) or common name:
  lomitapide
• Therapeutic area (MeSH):
  Hypercholesterolemia
• Anatomical therapeutical chemical (ATC) code:
  C10AX12
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Exceptional circumstances:

  This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

• Marketing authorisation holder:
  Chiesi Farmaceutici SpA
• Date of opinion:
  26/03/2026
• Status:
  Positive