Phase II study of oral fingolimod (FTY720) in multiple sclerosis: 3-year results.
Comi G, O’Connor P, Montalban X et al.; FTY720D2201 Study Group.
Editor’s note: Fingolimod is among the promising candidate pharmaceuticals that may achieve regulatory approval for the treatment of relapsing–remitting multiple sclerosis within the year. Based on the findings of an initial Phase II clinical trial (N Engl J Med 2006;355:1124–40), two Phase III studies have recently been published (N Engl J Med 2010;362:387–401, N Engl J Med 2010;362:402–15; reviewed in CML – Multiple Sclerosis 2010;2(2):50–2) that suggest superior efficacy of fingolimod compared with routine disease modifying treatment. Open-label extension phase analyses were also performed using the initial Phase II study population; the current publication reports the 36-month data from this extension.