The European Medicines Agency (EMA) has announced prescribing restrictions of alemtuzumab for multiple sclerosis (MS) while a safety review is undertaken. This action is in response to new reports of serious cardiovascular and immune-mediated adverse events including heart attack, stroke, cervicocephalic arterial dissection, neutropenia, and autoimmune hepatitis.
Alemtuzumab is a monoclonal antibody active against the CD52 cell surface antigen. This protein is present on T and B lymphocytes at high levels and to a lesser extent on natural killer cells, monocytes, and macrophages. Alemtuzumab is thought to improve relapsing forms of MS through the depletion and repopulation of lymphocytes. A higher strength of alemtuzumab (MabCampath®) is also registered in Australia for the treatment of B-cell chronic lymphocytic leukaemia.
The Therapeutic Goods Administration (TGA) has not announced any action at this stage. Actions recommended by international governing bodies such as the EMA and the US Food and Drug Administration (FDA) for patients with MS include:
- Consider ceasing therapy in patients who develop signs of the abovementioned adverse events;
- Advise patients to seek immediate medical attention if they experience any symptoms of these adverse events;
- Monitor vital signs before and during alemtuzumab infusions;
- Perform liver function tests before and during therapy;
- Promptly evaluate patients who develop signs of pathological immune activation; and
- Consider other treatment options for new patients.
These serious adverse events are thought to be rare. A total of four strokes and no heart attacks have been reported to the TGA in association with both alemtuzumab formulations since the drug was first approved in Australia in 2006.
- Department of Health. Database of Adverse Event Notifications – medicines. Woden: Therapeutic Goods Administration; 2019.
- European Medicines Agency. Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing. Amsterdam: EMA; 2019.
- Food and Drug Administration. FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab). Silver Spring: FDA; 2018.
- Lemtrada® (alemtuzumab) Australian approved product information. Macquarie Park: Sanofi-Aventis. Approved December 2018.