Following a resubmission.
Natalizumab (Tysabri®) is accepted for restricted use within NHS Scotland as single disease modifying therapy in highly active relapsing remitting multiple sclerosis (RRMS) only in patients with rapidly evolving severe RRMS defined by two or more disabling relapses in one year and with one or more gadolinium-enhancing lesions on brain magnetic resonance imaging (MRI) or a significant increase in T2 lesion load compared with a previous MRI.
In a post-hoc sub-group analysis of the pivotal trial, which included patients with rapidly evolving severe RRMS, it was associated with a significant reduction in the annualised relapse rate and the probability of sustained progression of disability over two years compared with placebo.
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Medicine details
- Medicine name:
- natalizumab 300mg concentrate for solution for infusion (Tysabri)
- SMC ID:
- 329/06
- Indication:
- as single disease modifying therapy in highly active relapsing remitting multiple sclerosis (RRMS)
- Pharmaceutical company
- Biogen Idec Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Resubmission
- Status
- Restricted
- Date advice published
- 10 September 2007