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

EMA

12 April 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. 

Patients being treated with Lemtrada who are benefitting from it may continue treatment in consultation with their doctor.

Read EMA press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , Review , Safety