Genzyme Corp. has filed with the European authority to expand the CE mark for Synvisc (hylan G-F 20) to include treatment of pain due to osteoarthritis (OA) 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.
"Our filing in Europe for approval of Synvisc in the ankle and shoulder reaffirms our commitment to the field of osteoarthritis and to pursuing new medical indications to help patients manage pain from OA," stated Ann Merrifield, president of Genzyme Biosurgery, the business unit of Genzyme Corp. that manufactures and markets Synvisc. "With approval in the ankle and shoulder, Synvisc will be one of the few visco-supplements available in Europe for treating OA pain in four major joints that is supported by strong clinical data."
Genzyme's filing for label expansion of Synvisc contains data from two clinical trials in the ankle and shoulder. The studies were prospective, multi-centre, open investigations that took place in several countries throughout Europe. Both studies found treatment with Synvisc to be well-tolerated, and data show that Synvisc significantly decreases pain due to OA in the ankle and shoulder and that the decreased pain effect is maintained for up to six months. Data from the ankle study have been accepted for presentation at the American College of Rheumatology meeting this fall in Washington, DC.
Genzyme expects the European regulatory review of the Synvisc label expansion to be complete by the end of the year.
Recently announced data from an independent investigator's clinical study found Synvisc to be superior in magnitude and duration of pain relief, functional improvement and patient satisfaction to another visco- supplementation product in treating patients with OA of the knee. These independent data were presented last June at the European League Against Rheumatism (EULAR) meeting in Amsterdam, The Netherlands.
Genzyme is utilizing evidence-based medicine in broadening Synvisc label claims that further establish its efficacy and safety. In addition, two meta-analyses in 2004 and 2006 also affirmed the clinical benefit of Synvisc and its class of visco-supplements. These studies were conducted using research methodologies that provide physicians and payers with tools to evaluate new treatments using an evidence-based approach. In addition to its efficacy in relieving OA knee pain, Synvisc, as a non-systemic treatment, has the advantage of avoiding the side effects associated with some non-steroidal anti-inflammatory drugs including the COX-2 inhibitors.
Synvisc is marketed in more than 60 countries and has been used to treat more than 3 million people. Synvisc is currently approved in the United States for treatment of pain due to osteoarthritis of the knee. Genzyme is pursuing a label expansion in the US that would include the hip indication.
Synvisc is indicated for the treatment of pain due to osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, for example, acetaminophen. Synvisc is currently approved in Europe and Canada to treat pain due to osteroarthritis in both the knee and hip.