Teva launches pivotal MS drug study

Teva has launched a pivotal study of a new higher dose of 40 mg/day dose of glatiramer acetate (GA) to the currently approved COPAXONE (GA) 20 mg/day to see if it can replicate positive results from a Phase II trial. In Phase II, patients taking the higher dose of GA had a 38 percent greater reduction in mean cumulative number of gadolinium (Gd)-enhancing lesions as measured by magnetic resonance images of the brain compared with those taking the COPAXONE (GA) 20 mg/day dose. In addition, compared to annual relapse rate prior to entry, patients taking GA 40 mg/day experienced a reduced mean on-trial relapse rate of 77 percent, whereas patients taking COPAXONE (GA) 20 mg/day experienced a 62 percent reduction. GA 40 mg/day was well-tolerated with a safety profile similar to the currently COPAXONE (GA) 20 mg/day.

- see the release [1] on Teva's plans

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