EU/3/15/1586: Orphan designation for the treatment of neurotrophic keratitis

Recombinant human nerve growth factor (cenegermin)

Overview

This medicine is now known as cenegermin.

On 14 December 2015, orphan designation (EU/3/15/1586) was granted by the European Commission to Dompé farmaceutici S.p.A., Italy, for recombinant human nerve growth factor for the treatment of neurotrophic keratitis.

Recombinant human nerve growth factor has been authorised in the EU as Oxervate since 6 July 2017.

Key facts

Active substance
Recombinant human nerve growth factor (cenegermin)
Intended use
Treatment of neurotrophic keratitis
Orphan designation status
Positive
EU designation number
EU/3/15/1586
Date of designation
14/12/2015
Sponsor
Dompé farmaceutici S.p.A.
Via Santa Lucia 6
20122 Milano
Italy
Tel. +39 02 583831
Fax +39 02 58383215
E-mail: info@dompe.com

Review of designation

On 19 May 2017, the Committee for Orphan Medicinal Products (COMP) completed its review of the designation EU/3/15/1586 for Oxervate (cenegermin, previously known as recombinant human nerve growth factor) as an orphan medicinal product for the treatment neurotrophic keratitis. 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 maintained.1


[1]The 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 the same 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: Oxervate (cenegermin) for the treatment neurotrophic keratitis (PDF/78.15 KB)


    First published: 29/08/2017
    Last updated: 29/08/2017
    EMA/337473/2017

  • Patients' organisations

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

    • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

    • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

    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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