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Wednesday, October 7, 2009

Lancet publication surrounding Phase III data from the COPAXONE® PreCISe study

The Lancet, Early Online Publication, 7 October 2009
COPAXONE® is the established global MS market-leading relapsing-remitting multiple sclerosis (RRMS) treatment based on the unsurpassed efficacy, safety and tolerability demonstrated over approximately 850,000 patient years of exposure.

The PreCISe results reinforce the importance and clinical benefit of early treatment initiation. Early treatment with disease-modifying therapies, such as COPAXONE®, is recommended by the National MS Society to prevent or delay the initiation or progression of irreversible neuronal damage. In the PreCISe study, investigators found:

· A 45 percent reduction in the risk of developing clinically definite MS in patients treated with COPAXONE® compared to those taking placebo; and,

· 25 percent of the patients treated with COPAXONE® delayed conversion to clinically definite MS by 115 percent (from 336 days for placebo to 722 days for COPAXONE®.)

Based upon those results, earlier this year, the FDA approved an expanded label for COPAXONE® to include the treatment of patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. Similar indications were also approved in the EU, Australia and Canada.


Study URL: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)61259-9/fulltext#

Lancet PreCISe Commentary Piece: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)61453-7/fulltext


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