EMA Reviews Safety of Alemtuzumab

April 15, 2019

EMA is evaluating the safety of Lemtrada (alemtuzumab) after new side effects were reported.

After reports of immune-mediated conditions, the European Medicines Agency (EMA) announced on April 12, 2019 that its Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing the safety Lemtrada (alemtuzumab), which is used to treat multiple sclerosis. New side effects associated with Lemtrada included problems with heart, blood vessels, lungs, and liver in addition to the immune system not working properly in some patients.

PRAC is limiting the use of Lemtrada to 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.” PRAC is also recommending that the product information be updated to include information about the new safety risks.

EMA is recommending the following to be included in the product information:

  • Immune-mediated conditions, including autoimmune hepatitis (with damage to the liver) and haemophagocytic lymphohistiocytosis (overactivation of the immune system which may affect different parts of the body)

  • 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).

The agency is recommending that healthcare professionals consider stopping treatment if patients develop signs of any of the above conditions. EMA is evaluating all safety data and is considering any additional measures that may be needed.

Alemtuzumab is a monoclonal antibody designed to recognize and attach to protein CD52, which is found on white blood cells of the immune system. According to EMA, “by attaching to CD52, alemtuzumab causes the white blood cells to die and be replaced, thereby reducing damaging activity of the immune system.”

Source: EMA