FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Launches Safety Review of Sanofi’s Lemtrada

April 23, 2019
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The European Medicines Agency is reviewing Sanofi’s multiple sclerosis drug Lemtrada (alemtuzumab) following reports of harmful autoimmune responses, including fatalities.

Pending results of the review, EMA said treatment should only be started in adults with relapsing-remitting MS that is highly active despite treatment with at least two disease-modifying therapies or where other disease-modifying therapies cannot be used.

The agency’s safety committee also has recommended an update of the product information to flag the immune-mediated conditions, including autoimmune hepatitis and overactivation of the immune system which may affect different parts of the body.

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