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Tuesday, September 16, 2014

Generic Copaxone for MS Passes Clinical Test






BOSTON -- A copycat version of the multiple sclerosis (MS) drug Copaxone, known generically as glatiramer acetate, performed similarly to the original product in a large head-to-head clinical trial, paving the way for it to win regulatory approval as a generic drug.
With T1 gadolinium-enhancing lesions during treatment months seven to nine as the primary endpoint in the trial -- which enrolled nearly 800 patients with relapsing-remitting MS -- outcomes were nearly identical: estimated geometric means for the primary endpoint were 0.42 for generic glatiramer acetate versus 0.39 for Copaxone, reported Jeffrey Cohen, MD, of the Cleveland Clinic.
The lesion ratio in the two groups was 1.097 (95% CI 0.884-1.362), well within the predefined limits of what would be considered clinically equivalent, Cohen told attendees at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting here, held jointly this year with its North American counterpart.


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