Genzyme Arthritis Treament Approval Delayed
Genzyme (NASDAQ: GENZ) announced today that approval of its knee osteoarthritis treatment Synvisc-One will be delayed until the second half of next year, or later, because the FDA has requested more data on the treatment. Synvisc-One combines three doses of an already approved treatment, Synvisc, into a single injection.
The news marks a second recent disappointment for Cambridge, MA-based Genzyme’s osteoarthritis program: in July another of its treatments, called hylastan, failed to meet efficacy targets in clinical trials. At the time, the company said it was abandoning development of hylastan to focus on Synvisc-One.
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