FDA Advisory Committee Recommends Approval of Synvisc-One
FDA Advisory Committee Unanimously Recommends Approval of Genzyme's Synvisc-One
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec 9, 2008 - Genzyme Corporation (Nasdaq: GENZ) 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.
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.
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 10,000 employees in locations spanning the globe and 2007 revenues of $3.8 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation.
With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
Genzyme's press releases and other company information are available at www.genzyme.com and by calling Genzyme's investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.
This press release contains forward-looking statements about Genzyme's future plans and strategies, including Genzyme's expectation that the FDA will act on its PMA by December 23, 2008. Forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These risks and uncertainties include, among others: whether the FDA determines that Synvisc-One can appropriately be approved for marketing in the US and whether it makes such determination by December 23rd; and the risks and uncertainties described in reports filed by Genzyme with the U.S. Securities and Exchange Commission, including without limitation the factors discussed under the caption "Risk Factors" in Genzyme's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2008. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and we undertake no obligation to update or revise the statements.
Genzyme and Synvisc are registered trademarks and Synvisc-One is a trademark of Genzyme Corporation or its subsidiaries. All rights reserved.
Contact: Genzyme Corporation
Lori Gorski, 617-768-9344
Catherine Tilton, 617-768-6881
Posted: December 2008