GENZYME FILES FOR SYNVISC IN ANKLE AND SHOULDER PAIN

Genzyme has filed in Europe to expand the CE mark for Synvisc (hylan G-F 20) to include treatment of pain due to osteoarthritis of the ankle and shoulder. Approval of a new label will provide opportunity to broaden the use of Synvisc beyond its current European-approved use in the knee and hip to the two additional joints.

Genzyme's filing for label expansion of Synvisc contains data from two clinical trials. The studies were prospective, multicenter, open investigations that took place in several European countries. Both studies found treatment with Synvisc to be well-tolerated, and data show that Synvisc significantly decreases pain in the ankle and shoulder, and that the decreased pain effect is maintained for up to six months.

The company expects the European regulatory review of the label expansion to be completed by the end of the year.