March 15, 2012
Phase III ALLEGRO study results showed laquinimod reduced the annual rate of relapses, slowed the progression of disability, and decreased brain tissue loss
Laquinimod was associated with favorable safety and tolerability profile
European Union (EU) regulatory submission planned in H2 2012
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced the publication of results from the laquinimod Phase III ALLEGRO study in the March 15 issue of The New England Journal of Medicine (http://www.nejm.org/).Data from the two-year study 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, while maintaining a favorable safety and tolerability profile in patients with relapsing-remitting multiple sclerosis (RRMS).
"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," said Principal Investigator, Professor Giancarlo Comi, Director of the Department of Neurology and Institute of Experimental Neurology at the San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Italy. "We are pleased to have the results published in The New England Journal of Medicine."The ALLEGRO results, along with results from the second global Phase III study of laquinimod, BRAVO, will be included in the application for regulatory approval planned for submission to the European Medicines Agency (EMA) in the second half of this year."The publication of the ALLEGRO results in a prestigious peer-reviewed journal is an important landmark as we continue to research and develop laquinimod," said Lesley Russell, Senior Vice President of R&D, Teva Global Branded Products. "We look forward to continuing to work with regulatory authorities in both the EU and the U.S. to bring this novel therapy to the MS community."
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