New MS Drug Submitted to FDA for Approval

CRegal Editor
  • On June 14, a new drug for treating MS called Lemtrada (alemtuzumab) was submitted to the US Food and Drug Administration for approval – the seventh step in the long approval process.  Lemtrada recently concluded Phase III studies.  These final steps of the application process could put Lemtrada on the market for patients by early 2015.


    [SLIDESHOW: The FDA Drug Approval Process]

    Lemtrada is a disease-modifying drug for patients with relapsing/remitting multiple sclerosis.  The drug is a monoclonal antibody and  depletes the circulation of T and B cells, which are thought to be responsible for the damaging inflammation associated with MS.  The drug then balances the immune system to alter the progression of the disease.  It is not believed to do any collateral damage to other parts of the immune system.

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    In clinical trials, Lemtrada was given by IV to patients a total of eight times over a period of two years.  The first course was given for five consecutive days, then administered for three consecutive days one year later.   The trials concluded that patients "were more than twice as likely to experience a sustained reduction in disability over two years than patients treated with Rebif." (For comparison, Rebif was injected three times per week over the course of the two year study). 


    The clinical trials found that 65 percent of patients treated with Lemtrada were relapse-free during the two years of the drug, as compared to only 47 percent among Rebif recipients.  The application, submitted by Genzyme in coordination with Bayer HealthCare, also found that a 49 percent reduction in relapse rate was observed in patients taking Lemtrada over Rebif. 


    [QUIZ: Relapsing-Remitting MS: Symptoms and Relapses]

    The clinical trials included a two-year study for safety and efficacy accompanied by a report of five years of safety follow-up.  According to the application, the only reported side effects were IV-related reactions and infections, which were generally mild to moderate in severity. 


    Lemtrada was also submitted to the European Medicines Agency for approval.


    What do you know about this drug?  Do you think it is promising?  Are you interested in trying Lemtrada?



    BTG. (14 June 2012). "Multiple Sclerosis Drug Lemtrada™ Submitted For Approval." Medical News Today. Retrieved from


    Multiple Sclerosis Resource Centre.  (2012).  "Lemtrada (alemtuzumab)."  Retrieved from

Published On: June 18, 2012