On April 12, 2019, the European Medicine Agency (EMA) has temporarily restricted the use of Lemtrada (alemtuzumab), while the review is ongoing8. The restriction says that the drug should only be started in adults with relapsing-remitting multiple sclerosis that is highly active despite treatment with at least two diseasemodifying 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.

The ongoing review of Lemtrada by EMA is followed by the reports of immune-mediated conditions (caused by the body's defense system not working properly) and problems with the heart and blood vessels with the medicine, including fatal cases.

Apart from this restriction, EMA's safety committee has recommended an update on Lemtrada to inform patients and healthcare professionals about:

  • Reports of immune-mediated conditions, including autoimmune hepatitis (with damage the liver) and haemophagocytic lymphohistiocytosis (overactivation of the immune system which may affect different parts of the body) occurring within 1–3 days of receiving the medicine;
  • Problems with the heart and blood vessels occurring within 1–3 days of receiving the medicine, including bleeding in the lungs, heart attack, stroke, cervicocephalic arterial dissection (tears in the lining of the arteries in the head and neck);
  • Severe neutropenia (low levels of neutrophils, a type of white blood cell that fights infections).
  • If patient observes any of these symptoms, then doctor will examine their condition and may consider stopping Lemtrada and switching to an alternative treatment. Patients are also asked to speak with doctor if they have any questions or concerns about treatment.
  • An in-depth review of Lemtrada is ongoing and further information will be provided as soon as it is available. While the review is ongoing, Lemtrada will only be prescribed to new patients if other medicines have not worked or are not suitable.
  • Doctors are being informed in writing of temporary restrictions on the prescription of Lemtrada pending the conclusion of an ongoing review of the medicine and inclusion of new safety warnings in the product information of Lemtrada.
  • Patients who develop signs of pathological immune activation should be evaluated immediately, and a diagnosis of haemophagocytic lymphohistiocytosis considered. Symptoms of immune activation may occur up to 4 years after the start of treatment.

About Lemtrada (alemtuzumab)

Lemtrada is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a protein called CD52 found on white blood cells of the immune system (the body's defenses). By attaching to CD52, alemtuzumab causes the white blood cells to die and be replaced, thereby reducing damaging activity of the immune system. Lemtrada is indicated to treat adults with relapsing-remitting multiple sclerosis, a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells.

The marketing authorization of Lemtrada was given to Sanofi Belgium in 2013.

Note- 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 its authorized use. Further information will be provided once the review of Lemtrada is concluded.


8 https://www.ema.europa.eu/en/documents/referral/lemtrada-article-20-referral-use-multiple-sclerosis-medicine-lemtrada-restricted-while-ema-review_en.pdf

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