Positive results from Teva's PreCISe Copaxone study

Isreal's Teva Pharmaceutical Industries says that new results from the PreCISe study demonstrated that early treatment with Copaxone (glatiramer acetate injection) 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, Teva has submitted an application for marketing authorization in Europe to the Medicines and Healthcare products Regulatory Agency (MHRA) for the extension of its indication to include the treatment of patients with a first clinical event suggestive of MS, and this is currently under review. A similar application requesting an expanded label for Copaxone will also be filed shortly with the US Food and Drug Administration.