Lemtrada

alemtuzumab

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

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

What is Lemtrada and what is it used for?

Lemtrada is a medicine that is used to treat adults with relapsing-remitting multiple sclerosis, a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells. ‘Relapsing-remitting’ means that the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions). Lemtrada is used for patients with active disease, based on the patient’s symptoms or scan results.

Lemtrada contains the active substance alemtuzumab.

How is Lemtrada used?

Lemtrada can only be obtained with a prescription. Treatment should be started and supervised by a doctor experienced in treating multiple sclerosis. Suitable equipment and staff should be available for managing the most common side effects and hypersensitivity (allergic) reactions. Patients should receive certain medicines before or during treatment to reduce the side effects.

Lemtrada is available as a liquid to be made up into a solution for infusion (drip) into a vein. An infusion lasts around 4 hours. Lemtrada is initially given in two courses of treatment: a first course of 12 mg daily for 5 days, followed 12 months later by a second course of 12 mg daily for 3 days. Up to two additional courses, each of 12 mg daily for 3 days, can be given at 12-month intervals.

For further information, see the package leaflet.

How does Lemtrada work?

In multiple sclerosis, the immune system (the body’s defences) incorrectly attacks the protective sheath around the nerves in the brain and spinal cord. The active substance in Lemtrada, alemtuzumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a protein called CD52. CD52 is found on lymphocytes, white blood cells that are part of the immune system. When alemtuzumab attaches to the lymphocytes it causes them to die, and they are replaced by new lymphocytes. The way alemtuzumab acts in multiple sclerosis is not fully understood, but it is believed to reduce the immune system’s damaging activity by causing the existing lymphocytes to die and to be replaced by new ones.

What benefits of Lemtrada have been shown in studies?

Lemtrada has been studied in two main studies involving 1,421 patients with relapsing-remitting multiple sclerosis. In both studies, Lemtrada was compared with another medicine for multiple sclerosis, interferon beta-1a. The first study involved previously untreated patients, while the second study involved patients whose disease had relapsed despite treatment. In both studies, the main measure of effectiveness was based on the number of relapses the patients had each year and the progression of disability after 2 years of treatment.

In the first study, the average number of relapses per year in patients given Lemtrada was less than half the number in patients given interferon beta-1a (0.18 versus 0.39), but there was no meaningful effect in terms of progression of disability. In the second study, the average number of relapses per year in patients given Lemtrada was around half the number in patients given interferon beta-1a (0.26 versus 0.52), and around 13% of patients given Lemtrada had a sustained progression of disability compared with around 21% of patients given interferon beta-1a.

Patients involved in the two main studies were followed-up for at least four years in an extension study, during which they were given up to two additional doses of Lemtrada, at one-year intervals, if their disease progressed. Over half of patients included in the extension study did not have disease progression and did not need additional Lemtrada infusions. For those patients who needed one or two additional infusions with Lemtrada, the number of relapses was lower, and disability progression was slower, compared with the previous year.

What are the risks associated with Lemtrada?

The most important side effects with Lemtrada are autoimmune conditions (where the body's defence system attacks normal tissue), including thyroid gland disorders, immune thrombocytopenic purpura (ITP, a bleeding disorder caused by low blood platelet counts) and kidney damage, as well as red and white blood cell disorders, reactions to the infusion and infections. The most common side effects with Lemtrada (which may affect more than 2 in 10 people) are rash, headache, fever and respiratory tract infections (throat and chest infections). For the full list of side effects reported with Lemtrada, see the package leaflet.

Lemtrada must not be used in patients with HIV and in patients with severe infections. For the full list of restrictions, see the package leaflet.

Why is Lemtrada approved?

The European Medicines Agency decided that Lemtrada’s benefits are greater than its risks and recommended that it be approved for use in the EU. The Agency considered that the benefit for patients with active disease had been shown in studies. With regards to safety, the Agency considered that educational materials must be provided to prescribers and patients to reduce the medicine’s risks.

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

The company that markets Lemtrada will ensure that doctors expected to prescribe the medicine receive educational materials containing important safety information, including details of the risk of autoimmune conditions, and a checklist covering the necessary screening, pre-treatment and long-term monitoring of patients. This will also contain a patient alert card and a guide for patients explaining participation in the risk management programme.

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

Other information about Lemtrada

The European Commission granted a marketing authorisation valid throughout the European Union for Lemtrada on 12 September 2013.

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

Name Language First published Last updated
Lemtrada : EPAR - Summary for the public BG = bălgarski 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public ES = español 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public CS = čeština 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public DA = dansk 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public DE = Deutsch 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public ET = eesti keel 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public EL = elliniká 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public EN = English 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public FR = français 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public IT = italiano 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public LV = latviešu valoda 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public LT = lietuvių kalba 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public HU = magyar 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public MT = Malti 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public NL = Nederlands 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public PL = polski 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public PT = português 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public RO = română 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public SK = slovenčina 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public SL = slovenščina 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public FI = suomi 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public SV = svenska 2013-09-25 2018-02-08
Lemtrada : EPAR - Summary for the public HR = Hrvatski 2013-09-25 2018-02-08

This EPAR was last updated on 08/02/2018 .

Authorisation details

Product details

Product details for Lemtrada
NameLemtrada
Agency product numberEMEA/H/C/003718
Active substance

alemtuzumab

International non-proprietary name (INN) or common name

alemtuzumab

Therapeutic area Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code L04AA34
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 Lemtrada
Marketing-authorisation holder

Genzyme Therapeutics Ltd

Revision4
Date of issue of marketing authorisation valid throughout the European Union12/09/2013

Contact address:

Genzyme Therapeutics Ltd
4620 Kingsgate
Cascade Way
Oxford Business Park South
Oxford
OX4 2SU
United Kingdom

Product information

Product information

08/12/2017  Lemtrada -EMEA/H/C/003718 -PSUSA/00010055/201703

Name Language First published Last updated
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08
Lemtrada : EPAR - Product Information HR = Hrvatski 2013-09-25 2018-02-08

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
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  
Lemtrada : EPAR - All Authorised presentations HR = Hrvatski 2013-09-25  

Pharmacotherapeutic group

Selective immunosuppressants

Therapeutic indication

Lemtrada is indicated for adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Lemtrada : EPAR - Public assessment report HR = Hrvatski 2013-09-25  
CHMP summary of positive opinion for Lemtrada HR = Hrvatski 2013-06-28  

Authorised

This medicine is approved for use in the European Union