The Orthopaedic and Rehabilitation Devices Panel (the Panel) met on December 19, 2008 at the Hilton Washington DC North/Gaithersburg located at 620 Perry Parkway in Gaithersburg, Maryland. The Panel met in order to provide advice and a recommendation on the approvability of Supplement 12 of the Premarket Approval (PMA) application P940015 for Synvisc One sponsored by Genzyme. This device is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
The sponsor and FDA presentations focused on the statistical analyses of the data, and the clinical significance of the results of the primary endpoint, a change in the Likert Scale. There was a 0.15 change on the 5 point Likert Scale in the least squares mean difference in the change of scores from baseline between Synvisc One and a saline control. The Synvisc One study results were found to be statistically significant in comparison to the saline control over 26 weeks. The Panel believed that the study results demonstrated modest effectiveness for Synvisc One, although the level of the treatment effect appeared comparable with other treatment modalities for knee osteoarthritis pain.
The Panel voted (5-0-0) to recommend that the PMA supplement application for Genzyme Synvisc One be Approved.
Contact: Ronald P. Jean, Ph.D., Executive Secretary, at 240-276-3676 or firstname.lastname@example.org.
Transcripts of this meeting may be purchased from:
Free State Reporting, Inc.
1378 Cape St. Claire Road
Annapolis, MD 21409
410-974-0947 or 800-231-8973 Ext. 103
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20851
(301) 827-6500 (voice)
(301) 443-1726 (fax)