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New analyses presented at AAN confirm efficacy of Gilenya® (fingolimod) across four key measures of Multiple Sclerosis

New pooled analyses were presented at the 66th American Academy of Neurology (AAN) Annual Meeting in Philadelphia, Pennsylvania from the pivotal and II trials for fingolimod (Gilenya®) in multiple sclerosis (MS). The analyses confirm the consistent efficacy of fingolimod across four key measures of MS (relapse rates, MRI lesions, brain volume loss and disability progression), which are used to assess the progression of a person’s MS.1 Addressing these four measures through effective treatment is key to improving the course of MS for people with this long-term fluctuating condition.

Tim Wright, Global Head of Development, Novartis Pharmaceuticals commented, “The new analyses at AAN confirm fingolimod’s robust efficacy across four key measures of MS disease activity, which is important to give patients as much time free of functional impairment.”

The pooled analyses from the FREEDOMS and FREEDOMS II trials showed that in patients with high disease activity treated in the past year, fingolimod demonstrated significant efficacy across the following measures:1

  • MRI lesions – new T2 lesion formation was reduced by 69% compared to placebo
  • Brain volume loss – fingolimod reduced the rate of brain volume loss by 46% compared to placebo
  • Disability progression – using a stringent six-month disability measure, fingolimod reduced disability progression by 45% compared to placebo.
  • Relapses – fingolimod reduced relapses (as measured by the annualised relapse rate) by almost half (48%) compared to placebo

The authors of the analyses concluded that treatment with fingolimod in patients failing prior treatment is efficacious across all four measures of disease activity, including disability progression.1

About the FREEDOMS and FREEDOMS II trials

FREEDOMS and FREEDOMS II are pivotal phase III, two-year, placebo-controlled trials that assessed the efficacy and safety of fingolimod.2,3 Although the study designs were similar, patient baseline characteristics were different between FREEDOMS and FREEDOMS II, including patient age, disease duration and previous treatment history.1,2,3

The pooled post-hoc analyses presented at AAN looked at clinical and MRI outcomes in patients previously treated in the past year who had at least one relapse in the previous year and either at least one gadolinium-enhancing T1 lesion or at least 9 T2 lesions at baseline; or a patient who had equal or more relapses in the year before baseline than in the previous year.1

The clinical and MRI outcomes were annualised relapse rate (ARR), time to three and six month confirmed disability progression, the percentage of change from baseline in brain volume (brain volume loss), the number of gadolinium-enhancing T1 lesions and the number of new/newly enlarged T2 lesions (MRI lesions).1


1. Bergvall et al. Efficacy of fingolimod in pre-treated patients with disease activity: pooled analyses of FREEDOMS and FREEDOMS II. Poster presented at: 66th AAN Annual Meeting; April 26 – May 3, 2014; Philadelphia, Pennsylvania. Poster P03.174.

2. Kappos L, Radue E-W, O’Connor P, et al; for FREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis.

3. Calabresi et al. Efficacy and safety of fingolimod versus placebo: primary outcomes from the phase 3 FREEDOMS II study in patients with relapsing-remitting multiple sclerosis. Abstract presented at ECTRIMS, New Orleans, 2012.

Novartis Pharmaceuticals