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FDA Approves Glatiramer Acetate for Symptoms Suggestive of MS NEW YORK -- March 4, 2009 -- The US Food and Drug Administration (FDA) has approved an expanded indication for glatiramer acetate injection (Copaxone) to include the treatment of patients with clinically isolated syndrome (CIS) suggestive of multiple sclerosis (MS). The approval was based on the results of a multicentre, double-blind, randomised, phase 3 trial which included a total of 481 patients presenting with a single clinical episode and magnetic resonance imaging (MRI) scans suggestive of MS over a period of up to 3 years. Patients received either glatiramer acetate injection 20 mg/day or placebo as a subcutaneous injection, and continued treatment for up to 3 years unless a second exacerbation was experienced. Patients who experienced a second exacerbation continued the trial on active treatment for an additional 2 years. The primary outcome was time to development of second exacerbation. Results showed that time to development of a second exacerbation was significantly delayed in patients treated with glatiramer acetate compared with placebo (hazard ratio [HR] = 0.55; 95% confidence interval [CI], 0.40-0.77; P = .0005). The cumulative probability of developing the second attack during the 3-year study period was significantly lower in the glatiramer acetate group versus the placebo group (24.7% vs 42.9%). An interim analysis was performed on data accumulated from 81% of the 3-year placebo-controlled study exposure. The study demonstrated that the 25th percentile of number of days to second exacerbation more than doubled from 336 days to 722 days (HR = 0.55; 95% CI, 0.40-0.77) in patients receiving glatiramer acetate compared with placebo. Moreover, there was a significant reduction in the number of new T2 lesions and in the number of T1-enhancing lesions in the glatiramer acetate arm compared with the placebo arm, both at year 1 and year 2 MRI scans. The most common side effects were redness, pain, swelling, itching, a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness. SOURCE: Teva Pharmaceutical Industries Ltd. E-mail this page to a friend or colleague! To print, use this version