The co announces new results from the PreCISe study, which demonstrated that early treatment with COPAXONE significantly reduced the risk of developing clinically definite multiple sclerosis by 45% compared to placebo (hazard ratio 0.55, p=0.0001). These data were presented as late-breaking science at the 60th Annual Meeting of the American Academy of Neurology in Chicago. Based on the PreCISE results, an application for marketing authorization in Europe to the Medicines and Healthcare products Regulatory Agency for the extension of its indication to include the treatment of patients with a first clinical event suggestive of MS, was submitted and is currently under review. A similar application requesting an expanded label for COPAXONE(R) will also be submitted shortly with the FDA.
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