Seven months after starting a safety review of Lemtrada (alemtuzumab), the Pharmacovigilance Risk Assessment Committee (PRAC) that oversees the safety of medicines approved in the European Union has issued final recommendations to minimize the risk of serious side effects linked to its use in relapsing-remitting multiple sclerosis (MS).
Specifically, reports of fatalities and severe effects were associated with immune complications that included autoimmune hepatitis (immune-caused liver damage) and hemophagocytic lymphohistiocytosis (a disorder that may affect several organs in the body), and hemolytic anemia (abnormal red cell breakdown). Some immune reactions could happen “many months” after treatment with Lemtrada, PRAC noted.
Reports also surfaced of severe and deadly heart, circulation, and bleeding disorders, including heart attack, stroke, bleeding in the lungs, and cervicocephalic arterial dissection (tears in the arteries from the head and neck). These adverse events, PRAC said, could develop within days of Lemtrada’s use.
While PRAC’s review was underway, the committee — an arm of the European Medicines Agency (EMA) — issued preventative measures restricting the use of Lemtrada (marketed by Sanofi Genzyme) to adult RRMS patients who failed prior treatments, or were ineligible for other disease-modifying therapies (DMTs).
The newly published recommendations replace those earlier measures.
PRAC now advises that Lemtrada use be restricted to:
- adults with RRMS who have “highly active disease despite adequate treatment” with at least one other DMT.
- adults with RRMS and rapid disease worsening, defined as at least two disabling relapses in a year and new brain lesions seen on MRI (magnetic resonance imaging) scans.
- Treatment with this vein infusion (drip) medicine take place only in hospitals with “ready access to intensive care facilities (ICUs) and specialists who can manage serious adverse reactions.”
PRAC also recommends that Lemtrada:
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