Olysio

simeprevir

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

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

What is Olysio and what is it used for?

Olysio is an antiviral medicine that contains the active substance simeprevir. It is used to treat chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus) in adults. Olysio is used in combination with other medicines.

How is Olysio used?

Olysio can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C.

Olysio is available as 150 mg capsules. The recommended dose is one capsule taken once a day with food for 12 weeks. Olysio must be used in combination with other medicines used to treat chronic hepatitis C, such as with peginterferon alfa and ribavirin or with sofosbuvir.

Before starting treatment with Olysio, patients should have a blood test to check what type of hepatitis C virus they are infected with, as Olysio is known to be less effective if the virus has a mutation (a change in the genetic material of the virus) called Q80K.

For further information, see the summary of product characteristics (also part of the EPAR).

How does Olysio work?

The active substance in Olysio, simeprevir, blocks the action of an enzyme called ‘NS3/4A serine protease’ in the hepatitis C virus, which is essential for the virus to multiply. This stops the hepatitis C virus from multiplying and infecting new cells. Several varieties (genotypes) of hepatitis C virus exist: Olysio has been shown to be effective against genotypes 1 and 4.

What benefits of Olysio have been shown in studies?

Olysio has been investigated in 3 main studies involving 1,178 patients with hepatitis C virus of genotype 1. The first two studies included previously untreated patients, while the third included patients whose infections had come back following treatment with interferon-based therapy. All three studies compared Olysio with placebo (a dummy treatment) when they were taken in combination with peginterferon alfa and ribavirin. The main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus 12 weeks after the end of treatment.

Olysio was shown to increase the proportion of patients who did not have any sign of hepatitis C virus in their blood:

  • Looking at the results of the first two studies together, around 80% (419 out of 521) of patients taking Olysio tested negative for hepatitis C 12 weeks after the end of treatment, compared with 50% (132 out of 264) of patients on placebo.
  • In the third study, around 80% (206 out of 260) of patients taking Olysio tested negative for hepatitis C 12 weeks after the end of treatment, compared with around 37% (49 out of 133) of patients on placebo.
    An analysis of these studies showed that Olysio was less effective in a sub-group of patients infected with hepatitis C virus genotype 1a that has the Q80K mutation.

Additional studies involving patients with hepatitis C virus of genotype 4 and patients with HIV co-infection showed results consistent with those in patients with genotype 1.

Olysio taken together with sofosbuvir has been investigated in one study involving 167 patients, which showed that this combination (with or without ribavirin) cleared infection with hepatitis C genotype 1 in over 90% of patients 12 weeks after the end of treatment. The study included patients with cirrhosis as well as patients who had not responded to previous therapy.

What are the risks associated with Olysio?

The most common side effects with Olysio (which may affect 5 or more people in 100) are nausea (feeling sick), rash, pruritus (itching), dyspnoea (difficulty breathing), increase in blood levels of bilirubin (an indication of liver problems) and photosensitivity reaction (sunburn-like reaction following exposure to light).

For the full list of side effects and restrictions, see the package leaflet.

Why is Olysio approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Olysio’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that, in both previously untreated patients and patients who had already been treated, adding Olysio to treatment with peginterferon alfa and ribavirin considerably increased the number of patients showing no sign of infection. The Committee also considered that the data available support the use of Olysio in combination with sofosbuvir in patients who cannot be given standard treatment including peginterferon alfa. Regarding its safety, Olysio was well tolerated and the side effects were manageable.

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

A risk management plan has been developed to ensure that Olysio 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 Olysio, including the appropriate precautions to be followed by healthcare professionals and patients.

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

Other information about Olysio

The European Commission granted a marketing authorisation valid throughout the European Union for Olysio on 14 May 2014.

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

Name Language First published Last updated
Olysio : EPAR - Summary for the public BG = bălgarski 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public ES = español 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public CS = čeština 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public DA = dansk 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public DE = Deutsch 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public ET = eesti keel 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public EL = elliniká 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public EN = English 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public FR = français 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public IT = italiano 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public LV = latviešu valoda 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public LT = lietuvių kalba 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public HU = magyar 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public MT = Malti 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public NL = Nederlands 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public PL = polski 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public PT = português 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public RO = română 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public SK = slovenčina 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public SL = slovenščina 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public FI = suomi 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public SV = svenska 04/06/2014 07/04/2015
Olysio : EPAR - Summary for the public HR = Hrvatski 04/06/2014 07/04/2015
Name Language First published Last updated
Olysio : EPAR - Risk-management-plan summary (English only) 04/06/2014  

This EPAR was last updated on 30/03/2016 .

Authorisation details

Product details

Product details for Olysio
NameOlysio
Agency product numberEMEA/H/C/002777
Active substance

simeprevir

International non-proprietary name (INN) or common name

simeprevir

Therapeutic area Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code J05AE14
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.

Publication details

Publication details for Olysio
Marketing-authorisation holder

Janssen-Cilag International N.V.

Revision5
Date of issue of marketing authorisation valid throughout the European Union14/05/2014

Contact address:

Janssen-Cilag International N.V.
Turnhoutseweg 30 
B-2340 Beerse 
Belgium

Product information

Product information

28/01/2016  Olysio -EMEA/H/C/002777 -II/0017

Name Language First published Last updated
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016
Olysio : EPAR - Product Information EN = English 04/06/2014 30/03/2016

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
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  
Olysio : EPAR - All Authorised presentations EN = English 04/06/2014  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Olysio is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients.

For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Olysio : EPAR - Public assessment report EN = English 04/06/2014  
CHMP summary of positive opinion for Olysio EN = English 21/03/2014