Genzyme's Carticel Gets FDA Panel OK

In an 11-zero vote, with one abstention, the US Food and DrugAdministration's Orthopedic and Rehabilitation Devices advisory committee indicated that Genzyme Tissue Repair's Carticel, its cartilage cell culturing service, provided a clinical benefit to patients with damage to the articular cartilage in the knee, but the panel also requested more data.

Carticel, which has been sold as an unregulated therapy since 1995, was reviewed at that time by the FDA but was not regulated because, as it comes from the patient's own body, it was deemed to fall outside existing policies. The agency permitted Genzyme Tissue Repair to market Carticel as an unregulated product following the review, until such a time as it developed a new policy for manipulated autologous structural cells.

First Product Reviewed Under New Policy Carticel is now the first product to be reviewed under the new policy, which was released at the end of February, and which covers human tissue and cell therapy products. The panel's vote will be taken into consideration by the agency when it reviews the company's Biologics License Application.