Osteoarthritis (OA) is the most common form of arthritis and is caused by the breakdown and loss of the cartilage of one or more joints.
Approval of this new indication will extend the application of Synvisc beyond its established use in knee and hip OA patients. Synvisc has been shown in European clinical trials to provide up to twelve months of pain relief in knee OA.
“We are eager to begin our marketing and sales effort and will continue to emphasize the strong clinical data that Synvisc has now generated in four major joints,” said Ann Merrifield, president of Genzyme Biosurgery, the business unit that manufactures and markets Synvisc.
The approval of Synvisc in the ankle and shoulder follows clinical studies that were conducted in Europe in these two joints. Both studies found treatment with one or two injections of Synvisc to be well-tolerated, and data show that Synvisc significantly decreases pain due to OA in the ankle and shoulder.
Genzyme expects to immediately begin marketing Synvisc in the European Union with its new label.