Genzyme Files for Approval of Single-Treatment Synvisc-One
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Genzyme Corp. announced that it has filed with the U.S. food and Drug Administration (FDA) for approval of Synvisc-One(TM), the single treatment of Synvisc® (hylan G-F 20) that provides up to six months of pain relief from osteoarthritis (OA) of the knee. If approved, Synvisc-One would be the only viscosupplementation product available worldwide proven to provide this duration of pain relief from a single injection. Genzyme believes this product line extension of Synvisc can simplify OA knee pain management and reduce the overall cost of therapy. The company expects the FDA to take action on this submission by the end of the year.
Synvisc is currently delivered through three intra-articular administrations of two milliliters each given at one-week intervals. Synvisc-One is delivered as three combined doses in one single six milliliter administration.
Genzyme's product marketing authorization (PMA) for Synvisc-One is based on final data from a prospective, randomized, double-blind, placebo-controlled study that involved 253 patients at 21 sites across Europe. Data from the study were presented last week at the European League Against Rheumatism annual meeting in Barcelona, Spain. Submission of these data to obtain a CE mark for Synvisc-One in Europe is expected to occur next month.
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