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Glatiramer Acetate Approved for Patients With Clinical Isolated Syndrome Suggestive of MS NEW YORK -- February 4, 2009 -- The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an expanded label for glatiramer acetate (Copaxone) injection to include the treatment of patients with clinical isolated syndrome (CIS) suggestive of multiple sclerosis (MS). The approval is based on results from the multicentre, double-blind, randomised, phase 3 Study to Evaluate the Effect of Early Glatiramer Acetate Treatment in Delaying the Conversion to CDMS of Subjects Presenting With a Clinically Isolated Syndrome (PreCISe). The study included a total of 481 patients presenting with a single clinical episode and magnetic resonance imaging (MRI) scans suggestive of MS. Patients included were those who had a unifocal disease manifestation. Patients were randomised to either glatiramer acetate injection 20mg/day or a placebo, and continued treatment for up to 3 years, unless a second attack was experienced and they were diagnosed with CDMS. Patients who converted to CDMS continued the trial on active treatment for an additional 2 years. The primary efficacy outcome was time to CDMS, based on a second clinical attack. Glatiramer acetate injection significantly reduced the risk of developing clinically definite MS (CDMS) by 45% versus placebo, and prolonged the quartile time to conversion to CDMS to 722 days versus 336 days in patients receiving placebo. Glatiramer acetate injection was very well tolerated in the PreCISe study, with 84% of patients completing the 3-year study period. SOURCE: Teva Pharmaceutical Industries Ltd. E-mail this page to a friend or colleague! To print, use this version