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Timothy L. Vollmer, MD
Department of Neurology
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Multiple Sclerosis Institute
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Thursday

 

FDA Agrees to Fast Review for Oral Drug Being Tested for MS

It was announced by the drug makers Teva Pharmaceutical Industries (Petach Tikvah, Israel) and Active Biotech (Lund, Sweden) that oral laquinimod has been designated by the U.S. Food and Drug Administration as a “Fast Track Product.” This designation should expedite its future review by the FDA after the sponsor submits results of current trials now underway.

A phase 3 study of laquinimod versus inactive placebo is currently underway in 1000 people with relapsing-remitting MS (also known as the Allegro study), and is fully enrolled. Another phase 3 study of laquinimod in comparison with inactive placebo or interferon beta-1a (Avonex®, Biogen Idec) is underway in 1200 people with relapsing-remitting MS (also known as the Bravo study), and is enrolling participants worldwide.
full story inNational MS Society.org

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