Genzyme Corporation announced that the FDA's Orthopaedic and Rehabilitation Devices Advisory Committee voted unanimously (5 - 0) in favour of approval without conditions of Synvisc-One (hylan G-F 20). The committee made this determination based on the clinical trial results Genzyme submitted to support the Premarket Approval (PMA) application supplement for Synvisc-One, an alternative treatment regimen for Genzyme's Synvisc that contains the same material and total treatment volume, but provides the 6 mL of hylan G-F 20 in a single injection. Synvisc-One is intended for the relief of pain associated with osteoarthritis (OA) of the knee.
The Advisory Committee also determined that the results of Genzyme's clinical study of Synvisc-One were both statistically significant and clinically meaningful, supporting the approval and labelling of the product. Synvisc-One is effective and safe for the treatment of pain due to OA of the knee. According to the committee analysis of Genzyme's secondary endpoints was adequate.
FDA will now evaluate the committee's input and make a determination about the next steps toward approval of Synvisc-One. Formal action is expected on Genzyme's PMA by December 23, 2008.
Genzyme senior vice president Alison Lawton said, "Genzyme appreciates the input of the advisory committee and we are pleased that they supported the approval of what will be the only single injection viscosupplement treatment available to OA patients. We look forward to working with FDA to determine the most expeditious path toward approval of Synvisc-One."
Synvisc-One has already been 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.
Synvisc is indicated for the treatment of pain due to osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, for example, acetaminophen.
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