LEMTRADA (alemtuzumab), selective immunosuppressant
NEUROLOGY - New medicinal product
Opinions on drugs -
Posted on
Dec 07 2017
Reason for request
Inclusion
- 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
Moderate |
- |
Insufficient |
Clinical Added Value
no clinical added value |
- |
Therapeutic use
- |
-
Economic analysis
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