Scenesse

afamelanotide

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This is a summary of the European public assessment report (EPAR) for Scenesse. 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 Scenesse.

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

What is Scenesse and what is it used for?

Scenesse is an implant used to treat patients with erythropoietic protoporphyria (EPP), a rare disease that causes intolerance to light.

In patients with EPP, exposure to light can lead to symptoms such as pain and swelling of the skin, which prevent patients from being able to spend time outdoors or in places with bright light. Scenesse is used to help prevent or reduce these symptoms so that these patients can lead more normal lives.

Because the number of patients with EPP is low, the disease is considered ‘rare’, and Scenesse was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 8 May 2008.

Scenesse contains the active substance afamelanotide.

How is Scenesse used?

Scenesse is only prescribed by specialist doctors in recognised centres for treating EPP and should only be used by doctors who have been properly trained.

One Scenesse implant is injected under the patient’s skin once every 2 months, before and during periods of high sunlight exposure, e.g. from spring to autumn. The number of implants per year depends on how much protection from the sun is needed. Three implants per year are recommended; the maximum number is 4. Patients should be observed for allergic reactions for 30 minutes after the injection of each implant.

For more information on how to use Scenesse, see the summary of product characteristics (also part of the EPAR).

How does Scenesse work?

The active substance in Scenesse, afamelanotide, is similar to a hormone in the body known as alpha-melanocyte stimulating hormone, which stimulates the production of a brown-black pigment in the skin. This pigment, known as eumelanin, is produced during exposure to sunlight to block the penetration of light into cells.

Patients with EPP have high levels of a substance called protoporphyrin IX in the body. Protoporphyrin IX is phototoxic and, when exposed to light, causes the painful reactions seen with this condition. By stimulating the production of eumelanin in the skin, Scenesse reduces the penetration of light through the skin, thus helping to prevent the painful reactions.

What benefits of Scenesse have been shown in studies?

Scenesse has been shown in a study to lead to an increase in the amount of time patients can spend in sunlight. In the study, involving 93 patients with EPP, patients were treated with either Scenesse or a placebo (a dummy treatment) over a six‑month period. Daily records of exposure to sunlight between 10 am and 6 pm showed that patients treated with Scenesse spent on average 116 hours in direct sunlight without experiencing pain during the six‑month period compared with 61 hours for patients treated with placebo.

What are the risks associated with Scenesse?

The most common side effects seen in studies with Scenesse were nausea (feeling sick), headache and reactions at the implant site (such as discoloration, pain and redness). These affected around 1 in 5 patients and were generally mild in severity.

Scenesse must not be used in patients with reduced liver or kidney function. For the full list of all side effects and restrictions with Scenesse, see the package leaflet.

Why is Scenesse approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Scenesse’s benefits are greater than its risks and recommended that it be given marketing authorisation. The CHMP noted that Scenesse led to an increase in the amount of time patients could spend in direct sunlight without experiencing pain. Although the additional time spent in sunlight was small, the Committee considered the possible improvements in quality of life, the unmet medical need in patients with EPP, and the mild side effects seen during short-term treatment with the medicine in deciding to recommend approval for Scenesse in the EU. The Committee also consulted individual patients and experts on their experience with Scenesse.

Scenesse has been authorised under ‘exceptional circumstances’. This is because it has not been possible to obtain complete information about the benefits of Scenesse, in part due to the rarity of the disease. Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.

What information is still awaited for Scenesse?

Since Scenesse has been approved under exceptional circumstances, the company that markets Scenesse will provide longer-tem data on the benefits and safety of the medicine from an EU registry of patients taking the medicine.

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

A risk management plan has been developed to ensure that Scenesse is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Scenesse, including information on the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets Scenesse will ensure that doctors receive educational material and are trained in how to use the medicine. Doctors will also be given information on the EU registry.

Further information can be found in the summary of the risk management plan.

Other information about Scenesse

The European Commission granted a marketing authorisation valid throughout the European Union for Scenesse on 22 December 2014.

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

Name Language First published Last updated
Scenesse : EPAR - Summary for the public BG = bălgarski 12/02/2015  
Scenesse : EPAR - Summary for the public ES = español 12/02/2015  
Scenesse : EPAR - Summary for the public CS = čeština 12/02/2015  
Scenesse : EPAR - Summary for the public DA = dansk 12/02/2015  
Scenesse : EPAR - Summary for the public DE = Deutsch 12/02/2015  
Scenesse : EPAR - Summary for the public ET = eesti keel 12/02/2015  
Scenesse : EPAR - Summary for the public EL = elliniká 12/02/2015  
Scenesse : EPAR - Summary for the public EN = English 12/02/2015  
Scenesse : EPAR - Summary for the public FR = français 12/02/2015  
Scenesse : EPAR - Summary for the public IT = italiano 12/02/2015  
Scenesse : EPAR - Summary for the public LV = latviešu valoda 12/02/2015  
Scenesse : EPAR - Summary for the public LT = lietuvių kalba 12/02/2015  
Scenesse : EPAR - Summary for the public HU = magyar 12/02/2015  
Scenesse : EPAR - Summary for the public MT = Malti 12/02/2015  
Scenesse : EPAR - Summary for the public NL = Nederlands 12/02/2015  
Scenesse : EPAR - Summary for the public PL = polski 12/02/2015  
Scenesse : EPAR - Summary for the public PT = português 12/02/2015  
Scenesse : EPAR - Summary for the public RO = română 12/02/2015  
Scenesse : EPAR - Summary for the public SK = slovenčina 12/02/2015  
Scenesse : EPAR - Summary for the public SL = slovenščina 12/02/2015  
Scenesse : EPAR - Summary for the public FI = suomi 12/02/2015  
Scenesse : EPAR - Summary for the public SV = svenska 12/02/2015  
Scenesse : EPAR - Summary for the public HR = Hrvatski 12/02/2015  
Name Language First published Last updated
Scenesse : EPAR - Risk-management-plan summary (English only) 12/02/2015  

This EPAR was last updated on 27/01/2016 .

Authorisation details

Product details

Product details for Scenesse
NameScenesse
Agency product numberEMEA/H/C/002548
Active substance

afamelanotide

International non-proprietary name (INN) or common name

afamelanotide

Therapeutic area Protoporphyria, Erythropoietic
Anatomical therapeutic chemical (ATC) code D02BB02
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.

Exceptional Circumstances

There were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

Publication details

Publication details for Scenesse
Marketing-authorisation holder

Clinuvel UK Limited

Revision2
Date of issue of marketing authorisation valid throughout the European Union22/12/2014

Contact address:

Clinuvel UK Limited
Devonshire House
60 Goswell Road
London EC1M 7AD
United Kingdom

Product information

Product information

01/12/2015  Scenesse -EMEA/H/C/002548 -IB/0006

Name Language First published Last updated
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016
Scenesse : EPAR - Product Information EN = English 12/02/2015 27/01/2016

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
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  
Scenesse : EPAR - All Authorised presentations EN = English 12/02/2015  

Pharmacotherapeutic group

Emollients and protectives

Therapeutic indication

Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Scenesse : EPAR - Procedural steps taken and scientific information after authorisation EN = English 28/10/2015 27/01/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Scenesse : EPAR - Public assessment report EN = English 12/02/2015 15/06/2015
CHMP summary of positive opinion for Scenesse EN = English 24/10/2014