Genzyme's Synvisc-One set for US device panel review
This article was originally published in Scrip
Genzyme's next-generation viscosupplementation product Synvisc-One will be reviewed by the USFDA's orthopaedic and rehabilitation devices advisory panel on December 9th. Genzyme is seeking an indication for the treatment of pain in patients with osteoarthritis of the knee who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics. The product is longer-acting version of Synvisc (hylan G-F 20), with one intra-articular injection providing six months of pain relief compared with three once-weekly injections for the original product. Genzyme filed the premarket approval application in June 2007. In November 2007 the FDA requested additional analysis and data, and the company responded in June. Genzyme expects FDA action on the application by December 23rd.