Posted by: Thixia | July 13, 2008

Disappointing Results in Copaxone Study

FDA — RxTrials Institute Drug Pipeline Alert



Teva Sees Disappointing Results in Copaxone Study


The 40-mg version of Teva’s blockbuster multiple sclerosis drug Copaxone did not demonstrate increased efficacy compared with a 20-mg dose, according to data from a Phase III trial.


The 1,155-patient, randomized, double-blind Copaxone (glatiramer acetate) study was conducted in 136 centers in North America, Argentina, Europe and Israel to measure the rate of confirmed relapses in subjects receiving the 20- or 40-mg version of the drug.


Of those treated with the 20-mg version, 78 percent remained relapse-free throughout the study. Patients who completed one year of treatment with the 20-mg dose experienced an annual relapse rate of 0.27 and a reduction of inflammatory activity as measured by an MRI, according to Teva.


While the 40-mg dose did not demonstrate increased efficacy in reducing the relapse rate, it maintained the favourable safety and tolerability profile of the lower dosage.



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