The FDA has approved an expanded indication for Copaxone (glatiramer acetate injection, from Teva) to include the treatment of patients who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with multiple sclerosis (MS). This approval was based on the results of a double-blind, randomized Phase 3 study, which indicated time to development of a second exacerbation was significantly delayed in Copaxone-treated patients compared to placebo. The cumulative probability of developing the second attack during the three year study period was significantly lower in the Copaxone group versus the placebo group.
Copaxone is already indicated for the reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).
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