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.
|disease||DOID||relapsing-remitting multiple sclerosis|
|disease||MESH||relapsing-remitting multiple sclerosis|
- Acute posterior multifocal placoid pigment epitheliopathy after alemtuzumab treatment for relapsing-remitting multiple sclerosis.
- Efficacy and safety of alemtuzumab in a real-life cohort of patients with multiple sclerosis.
- Immune cell derived BDNF does not mediate neuroprotection of the murine anti-CD52 antibody in a chronic autoimmune mouse model.