Advice

following a full submission

alemtuzumab (Lemtrada®) is accepted for use within NHS Scotland.

Indication under review: For adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

Two phase III studies comparing alemtuzumab with interferon beta-1a in treatment-naive (CARE-MS I) and treatment-experienced (CARE-MS II) patients with relapsing remitting multiple sclerosis both showed a statistically significant relative decrease in relapse rate of 55% and 49% respectively in favour of alemtuzumab. There was a significant reduction in the risk of sustained accumulation of disability over 6 months of 42% in CARE-MS II, but for CARE-MS-I, this was not statistically significant.

Please see additional notes section below.

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Medicine details

Medicine name:
alemtuzumab (Lemtrada)
SMC ID:
959/14
Indication:

For adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

Pharmaceutical company
Genzyme Therapeutics Ltd
BNF chapter
Malignant disease and immunosuppression
Submission type
Full
Status
Accepted
Date advice published
07 July 2014
Additional notes

The European Medicines Agency (EMA) restricted the use of alemtuzumab in January 2020 following a safety review.

The licensed indication of alemtuzumab (Lemtrada) is now as follows:  

Alemtuzumab is indicated as a single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups:

  • Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) or
  • Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

 

Further information is available on the EMA website.