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Label Expanded for Synvisc

European regulators approve the Genzyme drug for osteoarthritis of the ankle and shoulder.



received European regulatory approval for its joint pain drug Synvisc for treating osteoarthritis of the ankle and shoulder.

The new approvals were based on two European trials studying patients who received one or two injections of the drug.

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Data from the ankle study are expected to be presented at the American College of Rheumatology meeting in Washington this fall. The results of the shoulder study should be presented at the American Academy of Orthopaedic Surgeons meeting in San Diego in February.

Synvisc is currently approved in the U.S. for pain from osteoarthritis of the knee. Genzyme is pursuing a label expansion in the U.S. that would include osteoarthritis of the hip.

"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 group that manufactures and markets the drug.

Shares dipped 40 cents, or 0.6%, to $67.07 Monday.