FDA expands labeling for Copaxone.

The FDA has extended the labeling of Copaxone (glatiramer acetate) to include people with MS who have experienced a first clinical episode and have MRI features consistent with MS. The FDA based its decision on the findings of the "PreCISe" study, in which Copaxone reduced the risk of developing clinically definite MS by 45% versus placebo. Research suggests that damage to brain and spinal cord tissues can occur early in MS, and that early use of disease-modifying therapies can delay onset and forestall to some extent future disability. This expanded labeling for Copaxone adds another option for early treatment, and sends a signal to physicians and third-party insurers that this is an appropriate therapy for individuals with this condition.