FDA advisers back Genzyme's Synvisc-One

Genzyme has won a crucial vote by FDA advisers in favor of its single injection form of Synvisc, a therapy that eases knee pain by providing a cushion between joints. The five-member expert panel voted unanimously for the new formulation, which will replace a three-injection regimen that is currently approved. The experts said that there were no significant safety issues involved in their recommendation.

Genzyme conducted a clinical trial involving 253 patients that demonstrated a significant reduction in pain over a period of 26 weeks. The injection is designed to provide relief from the symptoms of osteoarthritis over a period of six months. Genzyme says that the new one-injection formulation will be more convenient for patients.

"We look forward to working with FDA to determine the most expeditious path toward approval of Synvisc-One," said Genzyme Senior Vice President Alison Lawton. Synvisc-One has been approved in the European Union and a number of Asian and Latin American countries. Nearly 10,000 patients have been treated with Synvisc-One since it was first approved last year.

- here's Genzyme's release
- read the AP report on the vote

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