FDA panel backs Genzyme's Synvisc-One for OA pain

US biotechnology firm Genzyme says that the Food and Drug Administration's Orthopedic and Rehabilitation Devices Advisory Committee voted unanimously (five to nil) in favor of approval without conditions of Synvisc-One (hylan G-F 20). The committee made this determination based on the clinical trial results Genzyme submitted to support the Premarket Approval application supplement for the product, an alternative treatment regimen for Genzyme's Synvisc that contains the same material and total therapy volume, but provides the 6mL of hylan G-F 20 in a single injection. Synvisc-One is intended for the relief of pain associated with osteoarthritis of the knee.

The Advisory Committee also determined the following:

- the results of Genzyme's clinical study of Synvisc-One were both statistically significant and clinically meaningful, supporting the approval and labeling of the product;