EU/3/02/107: Orphan designation for the treatment of partial deep dermal and full-thickness burns

proteolytic enzymes enriched in bromelain

Overview

On 30 July 2002, orphan designation (EU/3/02/107) was granted by the European Commission to Professor Keith Judkins, United Kingdom, for purified bromelain for the treatment of partial deep dermal and full-thickness burns.

Purified bromelain has been authorised in the EU as NexoBrid since 18 December 2012.

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in December 2022 at the end of the 10-year period of market exclusivity.

For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.

 

Key facts

Active substance
proteolytic enzymes enriched in bromelain
Medicine name
NexoBrid
Intended use
Treatment of partial deep dermal and full-thickness burns
Orphan designation status
Expired
EU designation number
EU/3/02/107
Date of designation
30/07/2002
Sponsor
MediWound Germany GmbH
Hans-Sachs-Strasse 100
Ruesselsheim Am Main
Hassia
65428
Germany

Review of designation

During its meeting of 3-4 October 2012, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/02/107 for NexoBrid (concentrate of proteolytic enzymes enriched in bromelain, previously known as purified bromelain) as an orphan medicinal product for the treatment of partial deep dermal and full-thickness burns. 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 satisfactory methods of treatment. As other satisfactory methods of treatment for patients with this condition are authorised in the European Union (EU), the COMP also looked at the significant benefit of the product over existing treatments. The COMP recommended that the orphan designation of the medicine be maintained*.


*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 a comparable therapeutic indication cannot be placed on the market.

Update history

DateUpdate
December 2022Product withdrawn from the Community Register of designated orphan medicinal products at the end of the 10-year period of market exclusivity.
September 2021The sponsor's address was updated. 
July 2013The sponsorship was transferred to MediWound Germany GmbH, Germany.
June 2010The sponsorship was transferred to Teva Pharma GmbH, Germany.

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: NexoBrid (concentrate of proteolytic enzymes enriched in bromelain) for the treatment of partial deep dermal and full-thickness... (PDF/114.88 KB)

    Adopted

    First published: 07/01/2013
    Last updated: 15/02/2023
    EMA/COMP/631996/2012

  • 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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