In its CRL the FDA said that it will not approve the application as it is.
The FDA further said that the 0.5ml formulation contained the same active ingredient as the currently marketed Copaxone, but that because the mechanism of action of Copaxone is not fully understood, even a formulation change could impact clinical outcomes.
The agency said that, unless the company provide a convincing argument that the new higher concentration/lower volume formulation does not have an impact on efficacy, an adequate and well controlled efficacy study will be needed to support efficacy of this new formulation.
Teva plans to continue working closely with the FDA to determine the most appropriate next steps regarding the application.
The sNDA was based on the SONG trial which examined a lower-volume injection of Copaxone containing 20mg of glatiramer acetate, the currently approved dose, in a 0.5ml injection.