EMA is recommending restriction of the use of the multiple sclerosis medicine Lemtrada (alemtuzumab) due to reports of rare but serious side effects, including deaths. New measures to identify and manage the serious side effects are also recommended. The side effects include cardiovascular disorders (affecting the heart, circulation and bleeding as well as stroke) and immune-related disorders (caused by the body’s defence system not working properly).

Lemtrada should now only be used to treat relapsing-remitting multiple sclerosis if the disease is highly active despite treatment with at least one disease-modifying therapy or if the disease is worsening rapidly. Lemtrada must also no longer be used in patients with certain heart, circulation or bleeding disorders or in patients who have autoimmune disorders other than multiple sclerosis.

The medicine should only be given in a hospital with ready access to intensive care facilities and specialists who can manage serious adverse reactions.

EMA has also recommended updating the physician’s guide and the patient information pack with advice on minimising the risk of serious cardiovascular disorders, which may occur shortly after a Lemtrada infusion (drip), and immune-related conditions, which may occur many months and possibly years after the last treatment.

These recommendations were issued by the EMA’s safety committee (PRAC) and have now been endorsed by the Agency’s human medicines committee (CHMP). They will replace the temporary measures introduced in April 2019 while the review of Lemtrada was under way. The changes come into force when the European Commission issues its decision.

Posted on the EMA website on 15 November 2019