European regulator restricts use of Sanofi MS drug Lemtrada

The European drug regulator has called for a review of Sanofi’s multiple sclerosis drug Lemtrada following reports of immune-related conditions and sometimes fatal problems with the heart and blood vessels.

The European Medicines Agency called for a restriction on use of Lemtruda (alemtuzumab) while the review is ongoing, ruling that it should only be started in adults with relapsing-remitting disease, that is highly active despite treatment with at least two disease-modifying therapies.

This recommendation prevents the drug being used as a first-line therapy, potentially affecting sales while the restriction is in place as doctors prioritise other medicines instead.

Patients being treated with Lemtrada may continue treatment in consultation with their doctor.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended and update of Lemtrada’s product information to include information about risks of immune-mediated conditions, including autoimmune hepatitis (with damage to the liver) and haemophagocytic lymphohistiocytosis - overactivation of the immune system which may affect different parts of the body.

Labels must also include information about problems with the heart and blood vessels occurring within one to three days of receiving the medicine, including bleeding in the lungs, heart attack, stroke, and cervicocephalic arterial dissection (tears in the lining of the arteries in the head and neck).

Severe neutropenia (low levels of neutrophils, a type of white blood cell that fights infections), is another risk the label must highlight.

The regulator warned healthcare professionals to consider stopping treatment in patients developing these symptoms, anyone taking Lemtrada who develops them should seek immediate medical attention.

This follows a less wide-ranging warning issued by the FDA last November, warning US doctors and patients about serious cases of stroke and tears in the lining of arteries in the head a neck that have been reported in MS patients treated with Lemtrada.

Alemtuzumab was first approved in Europe for chronic lymphocytic leukaemia under the brand name MabCampath, but in 2012 Sanofi's Genzyme unit controversially withdrew the drug from the market in this indication to prepare the way for its alternative use in MS.