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Friday, November 15, 2013

New data show Novartis' Gilenya® reduced brain volume loss by one third and confirm brain volume loss link with disability in MS patients

October 04, 2013

  • New four-year data showed that continued Gilenya treatment reduced brain volume loss by one third when compared to delaying Gilenya by two years.
  • MS patients with higher rates of brain volume loss were more likely to experience disease progression.
  • Patients who remained free of disease had consistently lower rates of brain volume loss compared to patients who experienced disease activity.
The digital press release with multimedia content can be accessed here:
Basel, October 4, 2013 Novartis announced today new data indicating that continued treatment with Gilenya® (fingolimod) led to a reduction in brain volume loss in patients with relapsing forms of multiple sclerosis (MS), and was associated with a higher proportion of patients remaining free of disability progression [1],[2]. These data were presented at the ongoing 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark.
Brain volume loss is emerging as one of the best indicators of disability progression over the long-term in MS, and is a topic of much interest within the MS medical community[3]. Increasingly, research focus is on treatments that will reduce the rate of brain volume loss. Gilenya is the only oral treatment for MS that has shown early and consistent slowing of brain volume loss, and the new data presented at ECTRIMS add to the growing evidence base of Gilenya's efficacy in MS and reinforce the correlation between brain volume loss and disability progression over the long-term[1].
"The data presented today are very encouraging because they are from studies that took place over four years and show that Gilenya both reduces brain volume loss and slows the pace of disability progression for patients with MS," said Dr. Timothy Wright, Global Head Development, Novartis Pharmaceuticals. "These are key treatment goals for patients with this chronic and debilitating illness."
Key findings
  • Collective four-year results from the pivotal FREEDOMS and FREEDOMS extension studies showed that patients who were treated continuously with Gilenya 0.5 mg experienced up to one-third less brain volume loss than patients who switched to Gilenya after receiving placebo for two years. Thus, delay in starting treatment with Gilenya by two years was associated with more brain volume loss[2].
  • Overall, patients who remained free of disease had consistently lower rates of brain volume loss compared to patients who experienced disease activity and MS progression. However, the benefit of Gilenya on brain volume loss was seen irrespective of whether patients were disease-free or had active disease[2]. (Disease activity was evaluated by assessing measures that give a broad evaluation of MS: disability progression, relapses and new brain lesions detected on magnetic resonance imaging scans.)
  • A separate analysis of three key studies (FREEDOMS, FREEDOMS II and TRANFORMS) showed a correlation between disability progression and increased brain volume loss, and this correlation increased over time[1].
  • Higher baseline MRI lesion volume and baseline active lesions both predicted subsequent loss of brain volume during the studies but patients treated with Gilenya had less brain volume loss than those treated with placebo or IFN beta 1a IM, irrespective of baseline lesion volume and count[4].
  • MS patients with higher brain volume loss were more likely to experience disability progression[1].
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