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.
The sponsorship was transferred to Teva Pharma GmbH, Germany, in June 2010 and subsequently to MediWound Germany GmbH, Germany, in July 2013.
Purified bromelain has been authorised in the EU as NexoBrid since 18 December 2012.
For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.
|Disease / condition||
Treatment of partial deep dermal and full-thickness burns
|Date of first decision||
|EU designation number||
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.
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/102.47 KB)
First published: 07/01/2013
Last updated: 07/01/2013
Sponsor's contact details
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.