Teva receives FDA complete response letter for glatiramer acetate 0.5mL injection sNDA

Dec 24 2010

Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for a lower-volume (0.5mL) injection of glatiramer acetate. Copaxone® containing 20mg of glatiramer acetate in 1ml is the global market leader in the treatment of relapsing-remitting multiple sclerosis (RRMS).

“Unless you can 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.”

The complete response letter stated that the FDA could not approve the application as submitted. The FDA noted 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 stated, "Unless you can 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."

This response supports Teva's belief that even slight changes to a glatiramoid like Copaxone® can significantly and unpredictably influence the efficacy, toxicity and immunogenicity profile of the compound. Teva intends 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. The trial was designed to explore whether a reduced-volume injection enhances the patient injection experience. The trial included nearly 150 patients in 21 centers in the U.S.