Genzyme Receives FDA Approval for New Labeling for Carticel®
Genzyme Corporation (Nasdaq: GENZ) announced today that the U. S. Food and Drug Administration (FDA) has approved new labeling for Carticel® (autologous cultured chondrocytes) based on the completion of a post-approval commitment study. This label incorporates safety and efficacy data from the Study of the Treatment of Articular Repair (STAR) as a result of Genzyme’s successful completion of this final confirmatory, post-marketing study.
“Genzyme has pioneered cartilage repair in the field of orthopaedics and sports medicine for more than a decade,” said Ann Merrifield, president of Genzyme Biosurgery, the division that manufactures and commercializes Carticel. “Now, the successful completion of our final FDA post-approval commitment further confirms Carticel’s safety and effectiveness for patients with troublesome and debilitating cartilage injuries in the knee. Carticel has already benefited thousands of patients with specific types of cartilage injuries where there traditionally have been limited treatment options. With this new data on-label, we hope to provide all appropriate patients access to therapy.”
The STAR study investigated the safety and effectiveness of Carticel in patients who had an inadequate response to a previous cartilage repair procedure in the knee. Investigators enrolled patients in 29 clinical centers in this prospective 4-year study, which achieved all of its endpoints. The data from the STAR study will be presented at the upcoming American Orthopaedic Society for Sports Medicine (AOSSM) Meeting on Sunday, July 15, 2007 in Calgary, Canada.
“Carticel has been established as a unique and valuable tool for orthopaedic surgeons in the treatment of patients with cartilage injuries in the knee. Accordingly, it is important that all appropriately indicated patients have access to this technology,” said David Levine, M.D., Vice President, Clinical Research for Genzyme Biosurgery. “Now that the post-approval commitments have been completed, we are confident that health plans that had yet to cover this treatment option will adopt the appropriate medical policy for Carticel.”
A Unique Cell Therapy
Carticel is used by orthopaedic surgeons to treat patients who have clinically significant articular cartilage lesions on the thigh bone part of the knee caused by acute or repetitive trauma that has not responded to a prior cartilage repair procedure. Carticel should only be used in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown. Carticel employs a unique process to grow a patient’s own cartilage cells for implantation to correct certain types of damage. The treatment starts when an orthopaedic surgeon trained in the use of Carticel provides Genzyme with a biopsy of healthy cartilage taken from a patient’s knee in an arthroscopic procedure. Technicians at Genzyme’s cell culture laboratory in Cambridge, MA use proprietary methods to grow millions of cells from this biopsy. The cells are then delivered to the hospital, where the surgeon implants them into the patient’s knee defect in a surgical procedure.
Carticel was the first cell therapy to be approved by the FDA. First introduced in March of 1995, Carticel received accelerated approval from the FDA in August of 1997 after the FDA instituted specific cell therapy guidelines. Under accelerated approval, the FDA required Genzyme to conduct confirmatory post-marketing studies.
To learn more about Carticel please visit www.carticel.com.
Cell Therapy Expertise at Genzyme
Genzyme has more than a decade of experience in developing and manufacturing autologous cell therapy products that have been used to treat thousands of patients. Epicel® (cultured epidermal autografts), a cell therapy for treating patients with severe burns, is also manufactured by Genzyme. Together, Carticel and Epicel represent the first such products ever brought to market in the United States, providing Genzyme with superior scientific and commercial expertise in this field.
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