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Monday, June 29, 2015

Novartis’ Gilenya Found to Have Long-Term Positive Effects on Patients with Relapsing-Remitting Multiple Sclerosis

A new study recently published in the Journal of Neurology, Neurosurgery and Psychiatryrevealed that long-term fingolimod therapy (marketed as Gilenya by Novartis) can maintain a low disease activity in patients with relapsing-remitting multiple sclerosis (RRMS). The study was conducted by an international team of researchers and is entitled “Long-term (up to 4.5 years) treatment with fingolimod in multiple sclerosis: results from the extension of the randomized TRANSFORMS study.
Multiple sclerosis is a chronic, progressive neurodegenerative disorder that results from an attack on the central nervous system (brain, spinal cord and optical nerves) by the body’s own immune system, causing inflammation and damage to the myelin layer that covers and protects neurons resulting in motor function impairment (coordination, balance, speech and vision), irreversible neurological disability and paralysis. It is estimated that more than 2.3 million people in the world suffer from MS, and 400,000 in the U.S. alone have the disease. The most frequent form of the disease is RRMS, which is clinically characterized by recurring episodes of neurological symptoms.
Fingolimod is an immunomodulating drug and an effective therapy for RRMS. The safety, tolerability and efficacy of two oral doses of fingolimod (0.5 or 1.25 mg once daily) were assessed in the 12-month, randomized, double-blind phase 3 clinical trial called TRANSFORMS (NCT00340834) in RRMS patients in comparison to treatment with interferon (IFN) beta-1a. The study revealed that fingolimod therapy at both doses significantly improved clinical and magnetic resonance imaging (MRI) outcomes with patients experiencing a reduction in the frequency of relapses in comparison to IFN beta-1a treatment.


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