Genzyme Biosurgery, a division of Genzyme Corp., has gained approval in the European Union to market Synvisc (Hylan G-F 20) for the treatment of osteoarthritis pain in the hip. Synvisc has been approved for use in the knee since 1995 in Europe and 1997 in the United States.
In addition, European regulatory officials have approved changing the product's label to indicate that Synvisc can provide up to one full year of relief from the pain and immobility associated with osteoarthritis (OA) in the knee, making it the longest-acting product of its kind in Europe. The expanded efficacy claim was approved in light of strong clinical evidence supportive of Synvisc's effectiveness beyond its previous six-month indication.
Synvisc is currently approved in more than 60 countries to treat OA knee pain, and has been used to treat more than 2.5 million patients worldwide. It is Genzyme Biosurgery's largest product, with worldwide sales of more than $250 million in 2001.
Genzyme Biosurgery sells Synvisc in Europe through a network of country-specific marketing partnerships, and through its own extensive sales and marketing organization. It expects to begin selling Synvisc for the treatment of hip OA in Europe during the second half of this year. It is estimated that there are approximately four million patients with symptomatic OA of the hip in Europe.
Genzyme Biosurgery also intends to pursue approval for the use of Synvisc to treat OA in the hip in the United States. It is currently in discussions with the U.S. Food and Drug Administration regarding the design of a pivotal clinical trial of this use. Synvisc is currently approved in the U.S. for treating pain from OA of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapies and simple analgesics, such as acetaminophen.