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Print Edition StoriesThursday, February 26, 2009
FDA OKs Genzyme’s long-lasting arthritis treatment
By Mass High Tech Staff
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Following the December 2008 recommendation of a committee, the U.S. Food and Drug Administration has granted marketing approval to Genzyme Corp. for its viscosupplement Synvisc-One for the relief of pain associated with osteoarthritis of the knee.
Synvisc-One is a single-injection version of Cambridge-based Genzyme’s already approved Synvisc (hylan G-F 20) treatment. The new, single-injection version can last up to six months, according to officials at Genzyme (Nasdaq: GENZ). Synvisc is a derivative of hyaluronic acid that is injected into the knee joint to replace the synovial fluid that often gets degraded in osteoarthritis patients.
The FDA asked for more data on Synvisc-One in November of 2007, after Genzyme had applied for approval.
In 2004, Genzyme entered into a deal that could cost up to $294 million to buy back the rights to Synvisc in the United States and five European countries from Wyeth.
Synvisc-One is already approved in the European Union and a number of Asian and Latin American countries.
Founded in 1981, Genzyme is a global biotech firm focused on rare inherited disorders, kidney disease, cancer, transplant and immune disease and diagnostic testing. With 11,000 employees worldwide, Genzyme reported a 2007 profit of $481 million on revenue of $3.8 billion.
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