Teva Pharmaceutical Industries Ltd. announced today that it has received a complete response letter from the US 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).

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 centres in the US.

Copaxone is indicated for the reduction of the frequency of relapses in RRMS, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. The most common side effects of Copaxone are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain.

Copaxone (glatiramer acetate injection) is now approved in 51 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries. In North America, Copaxone is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva Pharmaceutical Industries Ltd. In Europe, Copaxone is marketed by Teva Pharmaceutical Industries Ltd. and sanofi aventis. Copaxone is a registered trademark of Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients.