EMA review of Lemtrada following reports of immune related conditions and cardiovascular problems

EMA's safety committee (PRAC) has started a review of the multiple sclerosis medicine Lemtrada (alemtuzumab) following new reports of immune-mediated conditions, which are caused by the body's defence system not working properly, and problems with the heart and blood vessels with this medicine, including fatal cases.

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. Relapsing-remitting multiple sclerosis is a type of multiple sclerosis characterised by flare-ups of symptoms, followed by a time of recovery with few or no symptoms. In addition to the restriction, the PRAC has recommended an update of the product information for Lemtrada to inform patients and healthcare professionals about cases of immune-mediated conditions, problems with the heart and blood vessels and severe neutropenia. Patients being treated with Lemtrada who are benefitting from it may continue treatment in consultation with their doctor.

Comment: In 2018, the FDA warned about the potential for "rare but serious" cases of ischemic and hemorrhagic stroke and cervicocephalic arterial dissection associated with alemtuzumab therapy.