EMA restricts use of multiple sclerosis medicine, Lemtrada

Following reports of immune-mediated conditions and problems with the heart and blood vessels (including fatal cases), the EMA (European Medicines Agency) has started a review of the multiple sclerosis medicine, Lemtrada.

Lemtrada (alemtuzumab) is a medicine used to treat adults with relapsing-remitting multiple sclerosis (a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells). Relapsing-remitting is when the patient will relapse in between periods with few or no symptoms.  

Due to this ongoing review by the EMA, Lemtrada (which is given by infusion into a vein) should only be started in adults with relapsing-remitting multiple sclerosis that is highly active despite treatment with at least two multiple sclerosis medicines or where other disease-modifying therapies cannot be used.

Furthermore, patients already being treated with Lemtrada who are benefitting from it may continue treatment in consultation with their doctor.

EMA’s safety committee (the Pharmacovigilance Risk Assessment Committee – PRAC) has also 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 occurring within 1–3 days of receiving the medicine and severe neutropenia.

EMA will now evaluate all available data on the safety concerns with the medicine, and consider any additional measures necessary to protect patients and whether there should be changes in the authorised use.

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