Alofisel

darvadstrocel

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This is a summary of the European public assessment report (EPAR) for Alofisel. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Alofisel.

For practical information about using Alofisel, patients should read the package leaflet or contact their doctor or pharmacist.

What is Alofisel and what is it used for?

Alofisel is a medicine that is used to treat complex anal fistulas in adults with Crohn’s disease (an inflammatory condition of the gut) when a conventional or biological medicine has not worked well enough.

Fistulas are abnormal passages between the lower parts of the gut and the skin near the anus. Complex fistulas are those with several abnormal passages and openings, or with passages that go deep inside the body, or where there are other complications such as collection of pus.

Alofisel contains the active substance darvadstrocel, which comprises stem cells removed from fat tissue of adult donors. It is a type of advanced therapy medicine called a ‘somatic cell therapy product’. This is a type of medicine that contains cells or tissues that have been modified so that they can be used to cure, diagnose or prevent a disease.

Because the number of patients with anal fistula is low, the disease is considered ‘rare’, and Alofisel was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 8 October 2009.

How is Alofisel used?

Alofisel should be given only by specialist doctors experienced in the diagnosis and treatment of the condition for which it is used. The medicine can only be obtained with a prescription.

Alofisel is given just once. The patient is given an anaesthetic (either to put the patient to sleep or to numb the treatment area). After preparing the fistulas for treatment in an operating room, the contents of two vials (each containing 30 million cells) are injected around the internal openings and two further vials through the external openings into the walls of the fistula.

For further information, see the package leaflet.

How does Alofisel work?

Alofisel is made up of ‘mesenchymal stem cells’ from the fat tissue of a donor. To make this medicine, the cells are selected and cultivated in the laboratory to increase their number. When injected into the walls of the fistula, these cells can help to reduce inflammation and support the growth of new tissue. This encourages the fistula to heal and close.

What benefits of Alofisel have been shown in studies?

One main study, involving 212 patients with Crohn’s disease and complex anal fistulas, found Alofisel more effective than placebo (a dummy treatment) 24 weeks after treatment. Treatment with conventional or biological medicines had not worked in these patients. The main measure of effectiveness, called ‘combined remission’, was the closing of abnormal external openings together with lack of fluid collections of more than 2 cm associated with internal passages (since these are likely to re-open the fistula). Of the patients treated with Alofisel, combined remission occurred in almost 50% of patients (53 out of 107); this compared with 34% of patients (36 out of 105) receiving placebo.

What are the risks associated with Alofisel?

The most common side effects with Alofisel (which may affect up to 1 in 10 people) are anal abscess (a swollen area with a collection of pus), proctalgia (anal pain), anal fistula and pain during treatment.

Alofisel must not be used in patients with hypersensitivity (allergy) to bovine serum (the clear liquid in blood from cattle) or to any of the ingredients of Alofisel.

Why is Alofisel approved?

The European Medicines Agency decided that Alofisel’s benefits are greater than its risks and recommended that it be approved for use in the EU. Alofisel is of value in the treatment of complex anal fistulas that have not responded well to other treatments. Data on the safety of Alofisel are limited but they provide enough information on the pattern of side effects.

What measures are being taken to ensure the safe and effective use of Alofisel?

The company that markets Alofisel will provide educational material for healthcare professionals on how to give the medicine correctly and on the possibility of passing on an infection to the patient. The company will also complete a study to continue to collect information on the effectiveness and safety of Alofisel.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alofisel have also been included in the summary of product characteristics and the package leaflet.

Other information about Alofisel

The European Commission granted a marketing authorisation valid throughout the European Union for Alofisel on 23 March 2018.

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

Name Language First published Last updated
Alofisel : EPAR - Summary for the public BG = bălgarski 2018-04-04  
Alofisel : EPAR - Summary for the public ES = español 2018-04-04  
Alofisel : EPAR - Summary for the public CS = čeština 2018-04-04  
Alofisel : EPAR - Summary for the public DA = dansk 2018-04-04  
Alofisel : EPAR - Summary for the public DE = Deutsch 2018-04-04  
Alofisel : EPAR - Summary for the public ET = eesti keel 2018-04-04  
Alofisel : EPAR - Summary for the public EL = elliniká 2018-04-04  
Alofisel : EPAR - Summary for the public EN = English 2018-04-04  
Alofisel : EPAR - Summary for the public FR = français 2018-04-04  
Alofisel : EPAR - Summary for the public IT = italiano 2018-04-04  
Alofisel : EPAR - Summary for the public LV = latviešu valoda 2018-04-04  
Alofisel : EPAR - Summary for the public LT = lietuvių kalba 2018-04-04  
Alofisel : EPAR - Summary for the public HU = magyar 2018-04-04  
Alofisel : EPAR - Summary for the public MT = Malti 2018-04-04  
Alofisel : EPAR - Summary for the public NL = Nederlands 2018-04-04  
Alofisel : EPAR - Summary for the public PL = polski 2018-04-04  
Alofisel : EPAR - Summary for the public PT = português 2018-04-04  
Alofisel : EPAR - Summary for the public RO = română 2018-04-04  
Alofisel : EPAR - Summary for the public SK = slovenčina 2018-04-04  
Alofisel : EPAR - Summary for the public SL = slovenščina 2018-04-04  
Alofisel : EPAR - Summary for the public FI = suomi 2018-04-04  
Alofisel : EPAR - Summary for the public SV = svenska 2018-04-04  
Alofisel : EPAR - Summary for the public HR = Hrvatski 2018-04-04  

This EPAR was last updated on 04/04/2018 .

Authorisation details

Product details

Product details for Alofisel
NameAlofisel
Agency product numberEMEA/H/C/004258
Active substance

darvadstrocel

International non-proprietary name (INN) or common name

darvadstrocel

Therapeutic area Rectal Fistula
Anatomical therapeutic chemical (ATC) code L04
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 Alofisel
Marketing-authorisation holder

Tigenix, S.A.U.

Revision0
Date of issue of marketing authorisation valid throughout the European Union23/03/2018

Contact address:

Tigenix, S.A.U./ Marconi
1, Parque Tecnologico de Madrid
Tres Cantos
28760 Madrid
Spain

Product information

Product information

23/03/2018  Alofisel -EMEA/H/C/004258

Name Language First published Last updated
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Product Information HR = Hrvatski 2018-04-04  

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
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  
Alofisel : EPAR - All Authorised presentations HR = Hrvatski 2018-04-04  

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Alofisel should be used after conditioning of fistula.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Alofisel : Orphan maintenance assessment report HR = Hrvatski 2018-04-04  
Alofisel : EPAR - Public assessment report HR = Hrvatski 2018-04-04  
CHMP summary of positive opinion for Alofisel HR = Hrvatski 2017-12-15