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news.Phase III Allegro study results showed that oral once-daily laquinimod reduced inflammatory disease activity as measured by clinical relapses and magnetic resonance imaging (MRI) slowed disability progression and decreased brain tissue loss in patients with relapsing-remitting multiple sclerosis (RRMS).
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This is done while maintaining a favorable safety and tolerability profile in the patients, according to the study published in The New England Journal of Medicine.
Vita-Salute San Raffaele University, Italy, San Raffaele Scientific Institute director of the Department of Neurology and Institute of Experimental Neurology Giancarlo Comi said: "The positive findings from Allegro provided evidence that laquinimod represents a unique approach in the treatment of multiple sclerosis – one that offers relapse management along with a significant reduction in the key outcome measures correlated to irreversible nervous tissue damage."
Application including the Allegro results, along with the second global Phase III study of laquinimod Bravo results, will be submitted to the European Medicines Agency (EMA) in the second half of 2012, for regulatory approval.