NexoBrid

concentrate of proteolytic enzymes enriched in bromelain

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This is a summary of the European public assessment report (EPAR) for NexoBrid. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for NexoBrid.

What is NexoBrid?

NexoBrid is a medicine that contains the active substance ‘concentrate of proteolytic enzymes enriched in bromelain’. It is available as a powder and gel, which are mixed together to make a gel (2 g/22 g or 5 g/55 g).

What is NexoBrid used for?

NexoBrid is used in adults to remove eschar (dead tissue that is dried out, thick, leathery and black) from deep partial-thickness and full-thickness burns of the skin caused by heat or fire. Deep partial-thickness burns (sometimes called ‘second-degree’ burns) extend into a deep region of an inner layer of the skin called the dermis, while full-thickness burns (sometimes called ‘third degree’ burns) extend even deeper, through the whole dermis.

Because the number of patients with deep partial-thickness and full-thickness thermal burn wounds is low, the disease is considered ‘rare’, and NexoBrid was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 30 July 2002.

The medicine can only be obtained with a prescription.

How is NexoBrid used?

NexoBrid is applied to the area of burnt skin after the wound has been appropriately prepared. It should only be used in specialised burn centres, and should not be applied to more than 15% of the patient’s total body surface area. For a burn wound area of 100 cm2, NexoBrid 2 g/20 g gel is used. For a burn wound area of 250 cm2, NexoBrid 5 g/50 g gel is used. NexoBrid should be used within 15 minutes after mixing and should be left in contact with the skin for four hours. A second application is not recommended.

How does NexoBrid work?

The active substance in NexoBrid is a mixture of enzymes extracted from the stem of the pineapple plant. This mixture of enzymes acts as a debriding agent, a substance used to remove dead tissue from areas of the skin such as burn wounds, by dissolving the burn wound eschar. Removing the eschar helps to allow the living skin tissue to be treated and to heal.

How has NexoBrid been studied?

The effects of NexoBrid were first tested in experimental models before being studied in humans.

NexoBrid was studied in one main study involving 156 patients, who were hospitalised with deep partial-thickness or full-thickness burn wounds. The patients received either NexoBrid or standard debridement treatment (surgical or non-surgical treatments to remove the eschar) before receiving further treatment if required, such as surgery or a skin graft. The main measure of effectiveness was the proportion of deep partial thickness wounds that needed surgery to remove further skin tissue or that required a skin graft from another area of the patient’s body. The results were also considered for burn wounds of all thicknesses, including full-thickness wounds.

What benefit has NexoBrid shown during the studies?

The study showed that NexoBrid was more effective than standard of care treatment (surgical and non-surgical) at reducing the proportion of the deep partial thickness burn wounds that needed surgery to remove skin tissue or required a skin graft. In patients receiving NexoBrid, in around 15% (16 out of 106) of the wounds the eschar needed to be removed by surgery and around 18% (19 out of 106) required a skin graft, compared with around 63% (55 out of 88) and around 34% (30 out of 88) respectively in patients receiving standard debridement treatment. NexoBrid was also seen to be an effective debridement treatment for burn wounds of all thicknesses, including full-thickness wounds. In addition, it was found that NexoBrid removed eschar from wounds faster than standard treatments.

What is the risk associated with NexoBrid?

The most commonly reported side effects with NexoBrid are local pain, and pyrexia (fever) or hyperthermia (high body temperature). For the full list of all side effects reported with NexoBrid, see the package leaflet.

NexoBrid must not be used in people who are hypersensitive (allergic) to the active substance, pineapples, papain (an enzyme found in papaya fruit) or any of the other ingredients.

Why has NexoBrid been approved?

The CHMP concluded that NexoBrid effectively removes eschar from deep partial-thickness and full-thickness wounds and reduces the need for surgery to remove further skin tissue in deep partial-thickness wounds. The Committee considered that NexoBrid was shown to be an effective debridement treatment with an acceptable safety profile which complements available surgical techniques. Since some of the side effects seen, including delay in complete wound healing, may have been related to wound care procedures, the Committee decided that NexoBrid should only be used in specialised burn centres by healthcare professionals who have been trained to use it. The CHMP noted the importance of prompt skin grafting of areas of full-thickness and deep burn directly after debridement with NexoBrid, in line with the standard of care in European burn centres. The CHMP decided that NexoBrid’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe use of NexoBrid?

The company that markets NexoBrid must ensure that healthcare professionals in specialised burns centres who are expected to use NexoBrid receive appropriate training and an educational pack including a step-by-step guide to NexoBrid treatment, covering important safety considerations before and after using NexoBrid. The company will also carry out a long-term study in adults and children comparing NexoBrid with standard debridement treatment to investigate the outcome of patients including cosmetic considerations.

Other information about NexoBrid

The European Commission granted a marketing authorisation valid throughout the European Union for NexoBrid on 18 December 2012.

For more information about treatment with NexoBrid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
NexoBrid : EPAR - Summary for the public BG = bălgarski 07/01/2013  
NexoBrid : EPAR - Summary for the public ES = español 07/01/2013  
NexoBrid : EPAR - Summary for the public CS = čeština 07/01/2013  
NexoBrid : EPAR - Summary for the public DA = dansk 07/01/2013  
NexoBrid : EPAR - Summary for the public DE = Deutsch 07/01/2013  
NexoBrid : EPAR - Summary for the public ET = eesti keel 07/01/2013  
NexoBrid : EPAR - Summary for the public EL = elliniká 07/01/2013  
NexoBrid : EPAR - Summary for the public EN = English 07/01/2013  
NexoBrid : EPAR - Summary for the public FR = français 07/01/2013  
NexoBrid : EPAR - Summary for the public IT = italiano 07/01/2013  
NexoBrid : EPAR - Summary for the public LV = latviešu valoda 07/01/2013  
NexoBrid : EPAR - Summary for the public LT = lietuvių kalba 07/01/2013  
NexoBrid : EPAR - Summary for the public HU = magyar 07/01/2013  
NexoBrid : EPAR - Summary for the public MT = Malti 07/01/2013  
NexoBrid : EPAR - Summary for the public NL = Nederlands 07/01/2013  
NexoBrid : EPAR - Summary for the public PL = polski 07/01/2013  
NexoBrid : EPAR - Summary for the public PT = português 07/01/2013  
NexoBrid : EPAR - Summary for the public RO = română 07/01/2013  
NexoBrid : EPAR - Summary for the public SK = slovenčina 07/01/2013  
NexoBrid : EPAR - Summary for the public SL = slovenščina 07/01/2013  
NexoBrid : EPAR - Summary for the public FI = suomi 07/01/2013  
NexoBrid : EPAR - Summary for the public SV = svenska 07/01/2013  

This EPAR was last updated on 21/10/2014 .

Authorisation details

Product details

Product details for NexoBrid
NameNexoBrid
Agency product numberEMEA/H/C/002246
Active substance

concentrate of proteolytic enzymes enriched in bromelain

International non-proprietary name (INN) or common name

concentrate of proteolytic enzymes enriched in bromelain

Therapeutic area Debridement
Anatomical therapeutic chemical (ATC) code D03BA03
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for NexoBrid
Marketing-authorisation holder

MediWound Germany GmbH

Revision4
Date of issue of marketing authorisation valid throughout the European Union18/12/2012

Contact address:

MediWound Germany GmbH
Eisenstrasse 5
65428 Rüsselsheim
Germany

Product information

Product information

22/05/2014  NexoBrid -EMEA/H/C/002246 -II/0009

Name Language First published Last updated
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014
NexoBrid : EPAR - Product Information SV = svenska 07/01/2013 21/10/2014

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  
NexoBrid : EPAR - All Authorised presentations SV = svenska 07/01/2013  

Pharmacotherapeutic group

Preparations for treatment of wounds and ulcers

Therapeutic indication

NexoBrid is indicated for removal of eschar in adults with deep partial- and full-thickness thermal burns.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
NexoBrid : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 30/09/2013 21/10/2014

Initial marketing-authorisation documents

Name Language First published Last updated
NexoBrid : EPAR - Public assessment report SV = svenska 07/01/2013  
CHMP summary of positive opinion for NexoBrid SV = svenska 21/09/2012  

Authorised

This medicine is approved for use in the European Union