Apr 21 · Launched in UK. Price for two 150mg pre-filled syringes = £1,130 [9,10].
Apr 21 · FDA does not approve the company's supplemental Biologic License Application for subcutaneously delivered natalizumab for the treatment of relapsing multiple sclerosis. Rationale has not been publicly released. 
Apr 21 · Approved in UK .
Apr 21 · Approved in EU 
Jan 21 · 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 .
Jan 21 · 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 .
Oct 20 · Currently pre-registration in the EU. Has been filed using centralised procedure .
A selective adhesion-molecule inhibitor and binds to the α4-subunit of human integrins, which is highly expressed on the surface of all leukocytes, with the exception of neutrophils. SC formulation, dosed every 4 weeks.
MS estimated prevalence is 190 cases per 100,000 population. MS is more than twice as common in females than males. The highest prevalence for MS occurs in the 60 to 69 years age group for both sexes. The MS estimated incidence in England is between 8 and 11 new cases per 100,000 population .
Aug 11 · PII REFINE study to explore the effects of multiple regimens of natalizumab on disease activity and safety in participants with relapsing-remitting MS (RRMS) starts (NCT01405820). The study will explore dosing of natalizumab by subcutaneous and intravenous routes. Participants will be randomly assigned to 1 of 6 dosing regimens, blinded to natalizumab dose, but not route, for 60 weeks of treatment. 290 adults will be recruited in Belgium, Germany, France, Italy and Spain. Primary outcome is Cumulative number of combined unique active lesions (sum of the number of new gadolinium (Gd)-enhancing lesions and new or newly enlarging T2 hyperintense lesions not associated with Gd-enhancement on T1 weighted scans) based on brain magnetic resonance imaging (MRI) scans up to week 60 .