Genzyme Expects Synvisc-One Approval to Be Delayed
Biotechnology company Genzyme said Tuesday that U.S. regulators requested additional analyses and data related to its application to have Synvisc-One approved to treat knee pain from osteoarthritis.
The company said it now expects approval of the drug to be delayed in the United States until at least the second half of 2008.
Synvisc-One is a new formulation of Synvisc, or hylan G-F 20, designed to provide up to six months of pain relief in a single treatment.
Genzyme has also filed for approval of Synvisc-One in Europe and, if granted, would pursue marketing approvals in Asia and Latin America.