The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of Sanofi’s multiple sclerosis medicine Lemtrada (alemtuzumab).
The review comes following new reports of immune-mediated conditions, which are caused by the body's defence system not working properly, and problems with the heart and blood vessels with the medicine, unfortunately including fatal cases.
The committee advised that during the review, Lemtrada should only be started in adults with relapsing-remitting multiple sclerosis that is highly active despite treatment with at least two disease-modifying therapies, or where other disease-modifying therapies cannot be used.
It has also recommended an update of the product information for Lemtrada to inform patients and healthcare professionals about cases of immune-mediated conditions, problems with the heart and blood vessels and severe neutropenia.
The treatment is an antibody that binds to cells of the immune system (B and T cells), causing their destruction, but the way in which Lemtrada slows the decline of active relapsing–remitting multiple sclerosis is not fully understood.
The PRAC, which is continuing its evaluation, will make its final recommendations in July.
In November last year the US Food and Drug Administration issued a warning that serious cases of stroke and tears in the lining of arteries in the head and neck had been reported in MS patients after they began treatment with Lemtrada.