On 17 December 2010, orphan designation (EU/3/10/823) was granted by the European Commission to Dimensione Ricerca S.r.l., Italy, for lomitapide for the treatment of familial chylomicronaemia.

The sponsorship was transferred to Aegerion Pharmaceuticals, France, in February 2012 and subsequently to Aegerion Pharmaceuticals Limited, United Kingdom, in February 2015.

The sponsorship was transferred to Amryt Pharmaceuticals Designated Activity Company, Ireland, in March 2019.

Key facts

Active substance
Disease / condition
Treatment of familial chylomicronaemia
Date of first decision
EU designation number

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

Amryt Pharmaceuticals Designated Activity Company
90 Harcourt Street
Dublin 2
Co. Dublin D02 CR98
Tel. +353 1518 0208

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;

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