FDA Issues Complete Response Letter for Lower-Volume Glatiramer Acetate sNDA

(PresseBox) ( Jerusalem, Israel, )
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).

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.

About Copaxone®

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.

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About the Study

Patients (N=148) enrolled in an open-label randomized two-arm single crossover study. Half of the patients (n=76) were randomized to inject 20mg/1.0mL daily for the first 14 day period (Period 1). The other half of the patient group (n=72) injected 20mg/0.5mL daily during Period 1. During the second 14 day period (Period 2), the groups switched their injection volume formulation. The first group injected 20mg/0.5mL glatiramer acetate daily and the second group injected daily 20mg/1.0mL glatiramer acetate. Safety, tolerability, clinical and laboratory assessments occurred at the end of each period.
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