Massachusetts-based biotechnology company Genzyme Corporation said that it has received marketing approval for Synvisc-One™ from US Food and Drug Administration (FDA).
Synvisc-One™ (hylan G-F 20), a single-injection viscosupplementm, is intended for the relief of pain associated with osteoarthritis (OA) of the knee. This therapy has the potential to redefine the market for viscosupplementation products by extending the benefits of this therapeutic approach to a broader set of patients and reducing the total cost and burden of multiple injections.
The company said that Synvisc-One is administered through a single intra-articular injection. It is an alternative treatment regimen to Genzyme’s Synvisc® (hylan G-F 20), a three-injection viscosupplement approved in the United States in 1997 and in use worldwide for more than 16 years.
Synvisc-One contains the same material and total treatment volume as Synvisc but provides the 6 mL of hylan G-F 20 in a single injection. Viscosupplementation is a procedure in which hyaluronic acid or a derivative such as hylan G-F 20 is injected into the knee joint to replace synovial fluid that typically becomes degraded in patients with osteoarthritis. In synovial fluid, hyaluronic acid relieves pain and improves the knee joint’s natural shock absorbing abilities.
Jack Bert, M.D., President of the Arthroscopy Association of North America and Adjunct Clinical Professor at the University of Minnesota School of Medicine, said: “In just one visit to the doctor’s office, patients suffering from osteoarthritis may experience clinically significant pain relief for up to six months and for some patients this pain relief could potentially translate into a delay in the need for a total knee replacement. This single injection regimen will provide greater physician and patient convenience.”
Ann Merrifield, President of Genzyme Biosurgery, said: “Synvisc-One is an important therapy for OA of the knee because it delivers long-term pain relief through a single injection without the systemic side effects that can be caused by steroids and anti-inflammatory medication. We expect that the approval of Synvisc-One will be a significant growth driver for the Synvisc franchise.”
The company said that Synvisc-One is also approved in the European Union and a number of Asian and Latin American countries. Nearly 10,000 patients have been treated with Synvisc-One since it was first approved last year. Genzyme will begin making Synvisc-One available immediately.
