Just Approved: Lemtrada Available Soon in Europe

The European Commission has granted marketing authorization for Lemtrada and Genzyme plans to launch Lemtrada (alemtuzumab) soon. Lemtrada is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis  with active disease defined by clinical or imaging features. Lemtrada is an antibody treatment that is given in the vein over 5 days the first year and 3 days the second year.

In the CARE-MS I Trial, 581 early, active relapsing-remitting patients, who had received no prior MS therapy, were randomized to Rebif or alemtuzumab treatment. Compared to those MS patients on Rebif, those individuals on alemtuzumab had 55% less relapses.  A low percentage of patients had worsening disability on both treatments without a significant difference between Rebif and Alemtuzumab (11% and 8% respectively worsened).

In the CARE-MS II Trial,  Alemtuzumab (Lemtrada) IV treatment dropped new relapses by half (49.4%) compared to Rebif in a 2 year trial.   People with MS treated with alemtuzumab also were 42%  less likely to progress in disability than on Rebif and have less MRI activity.

The most common side effects of Lemtrada are infusion associated reactions, infections (upper respiratory tract and urinary tract),  and low white blood counts. Serious autoimmune conditions can occur such as low platelets (bleeding risks) and thyroid disease. A comprehensive plan will support early detection and management of these autoimmune diseases.

The FDA is currently reviewing Lemtrada for US approval, potentially by the end of 2013.  The MS Center for Innovations in Care has been a CARE-MS II Trial site.