FDA approves extended label for Copaxone

22 July 2001

The US Food and Drug Administration has approved expanded labeling forTeva Pharmaceutical's multiple sclerosis drug Copaxone (glatiramer acetate for injection).

The new label follows a recent study which examined various magnetic resonance imaging measures of disease activity and burden of disease. The primary outcome measure was the total number of enhancing lesions, which correlate to perivascular inflammation and blood brain disruption, on images over a nine-month period. The results demonstrated that Copaxone caused a significant reduction of MRI enhanced lesions, compared to placebo, in patients with MS.

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