Cosentyx

secukinumab

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

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

What is Cosentyx and what is it used for?

Cosentyx is an anti-inflammatory medicine used to treat adult patients with:

  • moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin) when the patient needs systemic (whole body) treatment;
  • psoriatic arthritis (inflammation of the joints associated with psoriasis) when disease-modifying anti-rheumatic drugs (DMARDs) do not work well enough;
  • ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine) when conventional treatments do not work well enough.

It contains the active substance secukinumab.

How is Cosentyx used?

Cosentyx can only be obtained with a prescription and treatment should only be given under the supervision of a doctor with experienced in diagnosing and treating the conditions for which Cosentyx is used.

The medicine is available as a powder used to make a solution for injection, or as a ready-to-use solution in a pre-filled syringe or pen injector. Cosentyx is given by injection under the skin as four weekly injections followed by monthly maintenance injections. The dose to be used depends on the disease to be treated. An improvement is usually seen within 16 weeks of treatment. The doctor should consider stopping treatment if no improvement has been seen during this time. Some patients with an initial partial improvement may see further improvements with continued treatment beyond 16 weeks. For further information, see the package leaflet.

How does Cosentyx work?

The active substance in Cosentyx, secukinumab, is a monoclonal antibody, a type of protein, designed to recognise and attach to a messenger molecule in the immune system called interleukin 17A. This molecule is involved in the inflammation and other immune system processes that cause psoriasis and are involved in psoriatic arthritis and ankylosing spondylitis. By attaching to and blocking the action of interleukin 17A, secukinumab reduces the activity of the immune system and the symptoms of the disease.

What benefits of Cosentyx have been shown in studies?

Studies showed that Cosentyx is effective in treating psoriasis, psoriatic arthritis and ankylosing spondylitis, with patients showing greater improvements with Cosentyx than with placebo (a dummy treatment) or with a comparator medicine, etanercept.

In 4 psoriasis studies involving 2,403 patients, 79% of those on Cosentyx achieved a 75% reduction in their PASI scores (a measure of disease severity and area of skin affected) after 12 weeks of treatment. This compares with 44% of those on a comparator medicine etanercept and 4% of those on placebo. In addition, 65% of patients given Cosentyx had clear or nearly clear skin, compared with 27% of patients given etanercept and 2% of those given placebo.

In a study of 397 patients with psoriatic arthritis, between 51% and 54% of patients on the approved doses of Cosentyx achieved a 20% reduction in ACR scores (painful, swollen joints and other symptoms) after 24 weeks. This compares with 15% of patients on placebo.

Finally, in a study of 219 patients with ankylosing spondylitis, 61% of patients given the approved dose of Cosentyx achieved a 20% reduction in ASAS scores (back pain, morning stiffness and other symptoms) after 16 weeks, compared with 28% of patients on with placebo.

What are the risks associated with Cosentyx?

The most common side effects with Cosentyx (which may affect more than 1 in 10 people) are upper respiratory tract infections (colds) with inflammation of the nose and throat (nasopharyngitis) and blocked or runny nose (rhinitis). Most of the side effects are mild to moderate in severity. Because Cosentyx may increase the risk of infection, it must not be given to patients with serious active infections such as tuberculosis.

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

Why is Cosentyx approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Cosentyx’s benefits are greater than its risks and recommended that it be approved for use in the EU. The medicine has been shown to be of substantial clinical benefit in patients with psoriasis, psoriatic arthritis and ankylosing spondylitis. The safety profile was considered reassuring, with the main concern related to mild infections.

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

A risk management plan has been developed to ensure that Cosentyx 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 Cosentyx, 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 Cosentyx

The European Commission granted a marketing authorisation valid throughout the European Union for Cosentyx on 15 January 2015.

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

Name Language First published Last updated
Cosentyx : EPAR - Summary for the public BG = bălgarski 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public ES = español 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public CS = čeština 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public DA = dansk 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public DE = Deutsch 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public ET = eesti keel 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public EL = elliniká 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public EN = English 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public FR = français 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public IT = italiano 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public LV = latviešu valoda 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public LT = lietuvių kalba 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public HU = magyar 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public MT = Malti 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public NL = Nederlands 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public PL = polski 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public PT = português 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public RO = română 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public SK = slovenčina 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public SL = slovenščina 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public FI = suomi 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public SV = svenska 02/03/2015 29/01/2016
Cosentyx : EPAR - Summary for the public HR = Hrvatski 02/03/2015 29/01/2016
Name Language First published Last updated
Cosentyx : EPAR - Risk-management-plan summary (English only) 02/03/2015  

This EPAR was last updated on 02/05/2016 .

Authorisation details

Product details

Product details for Cosentyx
NameCosentyx
Agency product numberEMEA/H/C/003729
Active substance

secukinumab

International non-proprietary name (INN) or common name

secukinumab

Therapeutic area Arthritis, PsoriaticPsoriasis
Anatomical therapeutic chemical (ATC) code L04AC10
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 Cosentyx
Marketing-authorisation holder

Novartis Europharm Ltd

Revision4
Date of issue of marketing authorisation valid throughout the European Union15/01/2015

Contact address:

Frimley Business Park
Camberley
GU16 7SR 
United Kingdom

Product information

Product information

01/04/2016  Cosentyx -EMEA/H/C/003729 -II/0008

Name Language First published Last updated
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016
Cosentyx : EPAR - Product Information EN = English 02/03/2015 02/05/2016

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
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015
Cosentyx : EPAR - All Authorised presentations EN = English 02/03/2015 11/05/2015

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Psoriatic arthritis

Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease modifying anti rheumatic drug (DMARD) therapy has been inadequate.

Ankylosing spondylitis

Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.”

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Cosentyx : EPAR - Public assessment report EN = English 02/03/2015 29/09/2015
CHMP summary of positive opinion for Cosentyx EN = English 21/11/2014