EMA's PRAC issues side effect risks warnings for Lemtrada and Xeljanz
European Medicines Agency’s safety committee Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions on the use of Lemtrada (alemtuzumab) in patients with relapsing remitting multiple sclerosis that is highly active despite adequate treatment with at least one disease-modifying therapy or if the disease is worsening rapidly with at least two disabling relapses in a year and brain-imaging showing new damage.
Lemtrada is marketed by French pharma major Sanofi (Euronext: SAN), which posted third-quarter sales of 57 million euros ($64.4 million).
The PRAC had issued interim measures on Lemtrada while reviewing reports of serious reactions. The PRAC completed the review and recommended that Lemtrada must no longer be used in in patients with certain heart, circulation or bleeding disorders or in patients who have auto-immune disorders other than multiple sclerosis.
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