Current licensed indication for Tysabri IV is as use single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for 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 .
Recommended for EU approval by CHMP - approval covers the same indications as the original product. Treatment [...] is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, with timely access to MRI. Home treatment is not recommended .
Currently pre-registration in the EU. Has been filed using centralised procedure .