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

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

Publication date: Apr 13, 2019

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.

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: 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.

At the start of the review, the PRAC has issued temporary recommendations to restrict the use of Lemtrada in new patients.

Concepts Keywords
Alemtuzumab Relapsing–remitting
Blood CD52
EMA Clinical medicine
European Commission Health
Healthcare Monoclonal antibodies
Immune System Autoimmune diseases
Inflammation Multiple sclerosis
Infusion Alemtuzumab
Medicine Sanofi
Monoclonal Antibody Sclerosis nerves inflammation
Multiple Sclerosis Healthcare professionals
Nerve Cells
Pharmacovigilance
Protein

Semantics

Type Source Name
gene UNIPROT SET
pathway BSID Immune System
gene UNIPROT CD52
disease DOID relapsing-remitting multiple sclerosis
gene UNIPROT PRAC1
disease MESH inflammation
disease MESH relapses
disease MESH relapsing-remitting multiple sclerosis
drug DRUGBANK Alemtuzumab
gene UNIPROT MUC1
gene UNIPROT ETFA
disease DOID multiple sclerosis
disease MESH multiple sclerosis

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