New Agent to Prevent Kidney Transplant Rejection Now Available
First Advancement in 12 Years Significantly Reduces Treatment Failure
Nutley, N.J., June 12, 1995 -- Roche Laboratories today announced the availability of CellCept (mycophenolate mofetil capsules) for the prevention of organ rejection in patients receiving kidney transplants. In clinical studies CellCept, when used in combination with cyclosporine and corticosteroids, substantially reduced the incidence of kidney rejection within the first six months following transplantation. CellCept was developed by Syntex Laboratories.
"CellCept represents an important new advance for patients undergoing renal transplantation," said Stephen J. Tomlanovich, MD, associate professor of clinical medicine, University of California San Francisco.
Solid organ transplantation has become standard therapy worldwide, with more than 18,000 transplants in the U.S. alone in 1993. Liver, heart, and heart/lung transplants are increasing the most rapidly, but kidney transplants remain the most common and successful. In 1993, 10,931 kidney transplants were performed, accounting for 60 percent of all solid organ transplants. The availability of immunosuppressive agents, along with improved surgical and organ-handling techniques, has dramatically raised kidney transplant success rates.
Despite advances made in organ transplantation, acute rejection has remained a major obstacle to maximizing transplant therapy. Acute rejection occurs when the body perceives the transplanted kidney as RforeignS and attempts to reject it. Patients are closely monitored for any sign of acute rejection, which is often manifested by a progressive loss of renal function. Scarring often occurs. Repeat episodes of acute rejection make it increasingly less likely that the kidney will ultimately be accepted by the body. About half of kidney transplant patients experience acute episodes of rejection during the first year after transplantation.
"The kidney transplant community is excited about this new immunosuppressant," said Alan R. Hull, MD, president, National Kidney Foundation, and clinical professor in the Department of Internal Medicine, University of Texas Southwestern Medical School, Dallas. "In clinical studies CellCept substantially reduced the incidence of acute rejection in the first six months."
CellCept Clinical Data
Safety and efficacy of CellCept were assessed in three double-blind, randomized, multicenter clinical trials. These studies compared CellCept's effectiveness, in combination with corticosteroids and cyclosporine, with azathioprine or placebo in preventing acute rejection episodes. Each study contained approximately 500 patients, and each was conducted in the United States, Canada, Europe, and Australia. Incidence of treatment failure in the CellCept treatment groups ranged from 30.3 to 38.8 percent across three studies compared to a range of 47.6 to 56 percent for the control group that received azathioprine or placebo. Treatment failure was defined as acute rejection confirmed through biopsy, or graft loss, early termination of drug treatment, or death.
Patients receiving CellCept as part of a combination immunosuppressive regimen are at increased risk of developing lymphomas and other malignancies, which is common to all immunosuppressive regimens. Principal adverse reactions associated with the administration of CellCept include diarrhea (31.0%), low white blood-cell count (23.2%), bacterial infection (13.4%) (generally CMV viremia), vomiting (12.5%) and a higher frequency of certain types of infections. CellCept should not be used in pregnant women unless the positive benefit justifies the potential risk to the fetus.
CellCept is available in 250-mg capsules. Recommended dosing is 1-g twice a day.
About Hoffmann-La Roche
Headquartered in Nutley, N.J., Hoffmann-La Roche Inc., is an affiliate of the multinational group of companies headed by Roche Holding Ltd. of Basel, Switzerland. One of the world's leading research-intensive health care companies, Roche has discovered, developed and introduced numerous important prescription pharmaceuticals. The company is also a major provider of diagnostic products and services as well as vitamins, premixes and other products for human and animal nutrition and health. Recognized for excellence in both biotechnology and traditional chemistry, Roche is also widely known for its current efforts in the research, development and commercialization of the polymerase chain reaction (PCR) technology, a revolutionary advance in diagnostics and other fields, including biomedical research, forensics and environmental testing.
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