The European Medicines Agency (EMA) has initiated a review of the multiple sclerosis (MS) medicine alemtuzumab (Lemtrada) following new reports of immune-mediated conditions and cardiovascular adverse events, with several deaths reported to date.
As a temporary measure while the review is ongoing, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is recommending that alemtuzumab should only be initiated in adults with relapsing-remitting MS that is highly active despite treatment with at least two disease-modifying therapies or where other disease-modifying therapies are contraindicated.
Patients who are currently receiving alemtuzumab and are showing clinical benefit may continue treatment.
In addition to the restriction, the PRAC has recommended an update to the product information for healthcare professionals about the risk of:
- immune-mediated conditions, including autoimmune hepatitis and haemophagocytic lymphohistiocytosis;
- cardiovascular events occurring within 1-3 days of receiving alemtuzumab, including diffuse alveolar haemorrhage, heart attack, stroke, cervicocephalic arterial dissection; and
- severe neutropenia.
The PRAC advises that healthcare professionals should consider stopping treatment in patients who develop signs of these conditions. For those being treated with alemtuzumab, vital signs should be monitored before and during infusion. If clinically significant changes are observed, discontinuation of infusion and additional monitoring, including electrocardiogram, should be considered.