FDA refuses approval for new Copaxone indication

The FDA refused approval for Teva Industries supplemental NDA for a new formulation of its multiple sclerosis drug, Copaxone (glatiramer acetate) - one containing a higher concentration/lower volume (20mg of drug infused in 0.5mL, versus the current formulation of 20mg/1.0mL). Teva's goal has been to offer patients an alternative that may potentially improve tolerability based on the results of the SONG study where the same amount of glatiramer acetate was formulated in half the volume. When results were reported last June, Teva claimed that patients in the trial reported significantly less pain and fewer injection site reactions . The FDA indicated that a new clinical trial may be needed to show that the new formulation works as well as the one that is already on the market. .