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Timothy L. Vollmer, MD
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Monday

 

COPAXONE(R) Is Approved For Treatment Of Patients With A First Clinical Event Suggestive Of Multiple Sclerosis

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved an expanded label for COPAXONE® (glatiramer acetate injection) to include the treatment of patients with clinical isolated syndrome (CIS) suggestive of multiple sclerosis (MS). This approval includes 24 EU member countries that take part in the MHRA "mutual recognition procedure". A similar application for the expanded COPAXONE® label is currently under review by the U.S. Food and Drug Administration (FDA).

The PreCISe study, conducted in patients with CIS demonstrated that COPAXONE® significantly reduced the risk of developing clinically definite MS (CDMS) by 45 percent versus placebo and prolonged the quartile time to conversion to CDMS to 722 days, versus 336 days in those patients receiving placebo.

Approval of an expanded label for COPAXONE® to include the treatment of CIS patients was also provided by the Australian Health Authority (Therapeutic Goods Administration, TGA).

Full story in Medical News Today



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