Lemtrada

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision
Current status:
Under evaluation

Overview

Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing

EMA has started a review of the multiple sclerosis medicine Lemtrada (alemtuzumab) following new reports of immune-mediated conditions (caused by the body’s defence system not working properly) and problems with the heart and blood vessels with the medicine, including fatal cases.

As a temporary measure while the review is ongoing, Lemtrada should only be started in adults with relapsing-remitting multiple sclerosis that is highly active despite treatment with at least two disease-modifying therapies (a type of multiple sclerosis medicine) or where other disease-modifying therapies cannot be used. Patients being treated with Lemtrada who are benefitting from it may continue treatment in consultation with their doctor.

In addition to the restriction, EMA’s safety committee (PRAC) has recommended an update of the product information for Lemtrada to inform patients and healthcare professionals about cases of:

  • immune-mediated conditions, including autoimmune hepatitis (with damage to the liver) and haemophagocytic lymphohistiocytosis (overactivation of the immune system which may affect different parts of the body);
  • problems with the heart and blood vessels occurring within 1–3 days of receiving the medicine, including bleeding in the lungs, heart attack, stroke, cervicocephalic arterial dissection (tears in the lining of the arteries in the head and neck);
  • severe neutropenia (low levels of neutrophils, a type of white blood cell that fights infections).

Healthcare professionals should consider stopping treatment in patients who develop signs of these conditions and patients should immediately seek medical help if they experience symptoms.

EMA will now evaluate all available data on the safety concerns with the medicine, and consider any additional measures necessary to protect patients and whether there should be changes in the authorised use.

Key facts

About this medicine
Approved name
Lemtrada
International non-proprietary name (INN) or common name

 alemtuzumab

Associated names
Lemtrada
About this procedure
Current status
Under evaluation
Reference number
EMEA/H/A-20/1483/C/3718/0028
Type
Article 20 procedures

This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.

Decision making model
PRAC-CHMP-EC
Authorisation model
Centrally authorised product(s)
Key dates and outcomes
Procedure start date
11/04/2019
EC decision date
29/04/2019

All documents

Procedure started

Under evaluation

  • List item

    Lemtrada Article 20 referral - Product information (PDF/840.18 KB)


    First published: 08/05/2019

  • List item

    Lemtrada Article 20 referral - Scientific conclusions (PDF/49.95 KB)


    First published: 08/05/2019

  • List item

    Lemtrada Article 20 referral - Assessment report on provisional measures (PDF/126.37 KB)

    Adopted

    First published: 08/05/2019
    EMA/249094/2019

  • Document description

    • Annex I - List of the medicines affected by the referral
    • Annex II - Scientific conclusions of the CHMP or CMDh
    • Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
    • Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
    • Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
    • Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
    • PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
    • PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
    • PRAC / CHMP or CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

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