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LEMTRADA (alemtuzumab), selective immunosuppressant

NEUROLOGY - New medicinal product
Opinions on drugs - Posted on Dec 07 2017

Reason for request


No clinical benefit demonstrated in the treatment of multiple sclerosis.


  • LEMTRADA has a Marketing Authorisation in adults with an active form of relapsing-remitting multiple sclerosis (RRMS), defined by clinical parameters or MRI of patients included in phase III studies, disease-modifying treatment-naïve patients or patients previously treated with at least one relapse in the year prior to inclusion or at least two in the 2 years prior to inclusion.
  • Given the serious adverse effects of the product with a significant residual effect and medium-term potential risks of its administration, its hospital use has been restricted.
  • LEMTRADA is reserved for severe forms of RRMS.
  • No comparison versus a treatment indicated in these highly active or rapidly progressing forms has been carried out.

Clinical Benefit




Clinical Added Value

no clinical added value


Therapeutic use




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