EU/3/08/541: Orphan designation for the treatment of erythropoietic protoporphyria

[Nle4, D-Phe7]-alfa-melanocyte stimulating hormone (afamelanotide)


On 8 May 2008, orphan designation (EU/3/08/541) was granted by the European Commission to Clinuvel UK Limited, United Kingdom, for [Nle4, D-Phe7]-alfa-melanocyte stimulating hormone for the treatment of erythropoietic protoporphyria.

[Nle4, D-Phe7]-alfa-melanocyte stimulating hormone has been authorised in the EU as Scenesse since 22 December 2014.

This medicine is now known as afamelanotide.

The sponsorship was transferred to Clinuvel Europe Limited, Ireland, in March 2019.

Key facts

Active substance
[Nle4, D-Phe7]-alfa-melanocyte stimulating hormone (afamelanotide)
Medicine name
Intended use
Treatment of erythropoietic protoporphyria
Orphan designation status
EU designation number
Date of designation

Clinuvel Europe Limited
10 Earlsfort Terrace
Dublin 2 D02 T380
Tel:  +353 (0) 1513 4932

Review of designation

During its meeting of 11 to 13 November 2014, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/08/541 for Scenesse (afamelanotide)1 as an orphan medicinal product for the treatment of erythropoietic protoporphyria. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other methods of treatment. The COMP recommended that the orphan designation of the medicine be maintained2.

1Previously known as [Nle4, D-Phe7]-alfa-melanocyte stimulating hormone.

2The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with a comparable therapeutic indication cannot be placed on the market.

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Scenesse (afamelanotide) for the treatment of erythropoietic protoporphyria (PDF/77.8 KB)

    First published: 17/02/2015
    Last updated: 17/02/2015

  • 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.

    EU register of orphan medicines

    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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