Smith & Nephew Orthopaedics has received Food & Drug Administration approval for Supartz, a joint fluid therapy to treat osteoarthritis.
In the United States, an estimated 20 million individuals suffer from osteoarthritis (OA). The US market for joint fluid therapy is the second largest in the world, with an estimated value in excess of $176 million. Based on the success of more than 100 million injections since its introduction in Japan in 1987 and backed by the results of recent clinical studies, Smith & Nephew is confident that Supartz will become the treatment of choice for physicians and OA patients.
Supartz is purified to remove all detectable DNA, protein and endotoxins.
As the first sodium hyaluronate injection in the world approved for human use
in treating osteoarthritis, Supartz has been the subject of 18 clinical
studies involving more than 10,700 patients, including patients of a Japanese
post market surveillance. Results worldwide have been superior and
statistically significant compared to placebo injections.
Supartz is manufactured by Seikagaku Corporation of Japan, a pioneer in
the field of glycoscience, and a leader in the research and development of
complex carbohydrates for medicines, pharmaceutical ingredients, reagents, and
diagnostics. The product will be co-labeled with both the Smith & Nephew and
Seikagaku names.