Teva to Submit Copaxone Applications
Israel’s Teva Pharmaceutical Industries reported positive results from an interim analysis of a Phase III trial investigating Copaxone in multiple sclerosis (MS) patients with clinical evidence of a single lesion and an MRI suggestive of the disease.
The multinational, multicenter, prospective, double-blind, randomized, PreCISe study included 481 patients who received either Copaxone (glatiramer acetate injection) 20 mg/day or placebo. Participants continued treatment for up to 36 months unless they were diagnosed with clinically definite MS.
The primary efficacy outcome was time to second attack. The proportion of patients developing clinically definite MS was 43 percent in the placebo group and 25 percent in the Copaxone group.
Based on these results, Teva will stop the study and file marketing authorization requests in Europe, the U.S. and Canada.