Natalizumab (branded and biosimilar) has a marketing authorisation as a single disease-modifying therapy in highly active relapsing–remitting multiple sclerosis for the following groups.
Patients with rapidly evolving severe relapsing–remitting multiple sclerosis defined by 2 or more disabling relapses in 1 year, and 1 or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load compared with a previous MRI. This patient group is referred to as the 'RES group'.
Patients with high disease activity despite treatment with beta interferon. This group is defined as patients who have failed to respond to a full and adequate course of a beta interferon. Patients should have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintensive lesions in cranial MRI or at least 1 gadolinium-enhancing lesion. This patient group is referred to as the 'suboptimal therapy group'.