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FDA Advisory Committee Recommends Approval of Synvisc-One

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme Corporation (Nasdaq: GENZ - News) today announced that the FDA’s Orthopaedic and Rehabilitation Devices Advisory Committee voted unanimously (5 – 0) in favor 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 the following:

  • The results of Genzyme’s clinical study of Synvisc-One were both statistically significant and clinically meaningful, supporting the approval and labeling of the product.
  • Synvisc-One is effective and safe for the treatment of pain due to OA of the knee.
  • The analysis of Genzyme’s secondary endpoints was adequate.
The 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.

About Synvisc
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. Synvisc is currently approved in Europe and Canada to treat pain due to osteoarthritis in the knee and hip, and also approved in Europe for the ankle and shoulder indications, covering the major joints.

In clinical trials, the most commonly reported adverse events were transient local pain, swelling, and/or effusion in the injected knee. In some cases, these symptoms have been extensive. Other side effects such as rash have been reported rarely. Synvisc is contraindicated in patients with known hypersensitivity to hyaluronan products or patients with infections in or around the knee. Healthcare practitioners should exercise caution when using Synvisc in patients allergic to avian proteins, feathers, or egg products; who have evidence of venous or lymphatic stasis in the leg to be treated; or who have severe inflammation in the knee joint to be treated. Patients should be advised to avoid strenuous or prolonged weight-bearing activities after treatment. Strict adherence to aseptic technique must be followed to avoid joint infection. The safety and effectiveness of Synvisc in children and in pregnant or lactating women have not been established. It is unknown whether Synvisc is excreted in human milk.

Source: Genzyme Corporation

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