New data show Novartis' Gilenya® reduced brain volume loss by one third and confirm brain volume loss link with …

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.

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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

About multiple sclerosis While its exact cause is unknown, multiple sclerosis (MS) is an autoimmune disease of the central nervous system (CNS) that causes the body to turn against itself by mistaking normal cells for foreign cells[6]. In MS the myelin sheath, the covering that protects nerve fibers, is damaged by the inflammation that occurs when the body`s immune cells attack the nervous system[7]. This neuro-inflammatory damage can occur in any area of the brain, optic nerve and spinal cord and cause a range of physical and mental problems including loss of muscle control and strength, vision, balance, sensation and mental function[8]. Up to 2.5 million people worldwide are affected by MS[9], most often younger people between the ages of 20 and 40[10].

About Gilenya Gilenya is the first oral therapy approved to treat relapsing forms of MS and the first in a new class of compounds called sphingosine 1-phosphate receptor modulators[11],[12]. It is thought that Gilenya works in two ways against the destructive processes that drive MS disease progression by affecting not only the immune system to reduce inflammatory damage but also the CNS to promote neuroprotection and repair[12]. Gilenya is thought to act by preventing lymphocytes (the cells that cause inflammation and damage in the CNS) from leaving the lymphoid tissues, thus reducing their entry into the central nervous system and potential for damage[11],[12]. Gilenya is also able to cross the blood-brain barrier and act on the neurodegeneration process in the brain and spinal cord[11],[12].

Gilenya is the only oral MS treatment that provides early and long-term reduction in the rate of brain volume loss and high efficacy across all 4 disease activity measures (disability progression, relapses, MRI activity, brain volume loss)[13]-[18]. In clinical trials, Gilenya exhibited a well-characterized safety profile and very good tolerability profile[14],[15]. The most common side effects were headache, hepatic enzymes increased, influenza, sinusitis, diarrhea, back pain, and cough[14],[15]. To date, more than 71,000 patients have been treated with Gilenya demonstrating a positive benefit-risk profile in clinical study and real-world settings[19].

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New data show Novartis' Gilenya® reduced brain volume loss by one third and confirm brain volume loss link with ...