FDA Agrees To Fast Review For Oral Drug Being Tested For MS

Main Category: Multiple Sclerosis
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 17 Feb 2009 - 2:00 PDT

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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.

Multiple sclerosis occurs when the immune system mistakenly attacks the myelin sheath on nerve fibers, and also damages other brain and spinal cord tissues. Laquinimod is believed to affect this immune attack. In an earlier phase 2 study involving 306 people with relapsing-remitting MS, laquinimod reduced disease activity by 40.4% compared with inactive placebo. (Lancet 2008; 371: 2085-92)

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.

National MS Society

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