FDA Advisory Committee Voted on Lemtrada.

The FDA Advisory Committee met today and voted  on specific questions regarding Lemtrada (alemtuzumab).  The committee had concerns about the studies not being well-controlled since patients were randomized to either Rebif or Lemtrada, but knew which medication they were taking (non-blinded).  However, by a vote of 12 to 6, the committee voted that the trials did demonstrate substantial evidence of effectiveness.  In addition, the panel supported that the benefits of Lemtrada outweighed the risks.  The committee was not in favor of first-line use.  The final ruling will be by the FDA after reviewing the committee’s input.   The MS Center for Innovations in Care at Missouri Baptist Medical Center is a site for the CARE-MS II Trial of alemtuzumab.     

Lemtrada is an antibody treatment that is given in the vein over 5 consequetive days the first year and 3 days the second year.  The medicine causes a loss of T and B cell immune cells that are involved the immune attack associated with multiple sclerosis.

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%) 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),  thyroid disease and kidney disease.