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Genzyme’s Synvisc-One

This article was originally published in The Gray Sheet

Executive Summary

Genzyme expects approval of its next-generation Synvisc osteoarthritis treatment for the knee to be delayed in the United States until at least the second half of 2008, since FDA has requested additional analyses and data on the PMA application, the firm says Nov. 13.Synvisc-One is a single-treatment version expected to provide up to six months of pain relief. The current version of Synvisc is delivered in three administrations at one-week intervals (1"The Gray Sheet" Jan. 1, 2007, p. 9). The firm is waiting for a CE mark on the product in Europe, and if approved there, will pursue marketing approval in Asia and Latin America

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