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FDA Approves CellCept Combination For Heart Transplantation NUTLEY, NJ -- February 12, 1998 -- The United States Food and Drug Administration has granted marketing clearance to Hoffmann-La Roche Inc. for the expanded use of CellCept(R) (mycophenolate mofetil), to be used in combination with cyclosporine and corticosteroids for the prevention of organ rejection in patients undergoing heart transplants. The FDA based its decision on results of a trial which showed that CellCept was safe and effective in heart transplantation. The 650-patient trial was the first prospective, double-blind, controlled study to examine the effects of immunosuppressants on acute rejection and survival in heart-transplant patients. "Because there is a national shortage of organ donors, physicians must do everything to prevent the available organs from being rejected," said Dr. Donna Mancini, medical director of cardiac transplantation, divisions of circulatory physiology and cardiology, at Columbia Presbyterian Medical Center in New York. "CellCept offers physicians and patients a new standard of care in the field of heart transplantation by helping to ensure that those hearts that are available have a higher rate of success." Each year, about 3,900 people in the United States are put on a waiting list for a heart transplant and only 2,000 people will receive one. Of those who receive a heart transplant, approximately 300 will experience a rejection episode. CellCept is an immunosuppressant that was approved by the FDA in May 1995 for use in combination with cyclosporine and corticosteroids for the prevention of organ rejection in kidney-transplant patients. In kidney-transplant patients, CellCept has been shown to significantly reduce the incidence of rejection within the first six months of kidney transplantation, without any observed additional kidney or liver toxicities. The principal adverse reactions associated with the administration of CellCept include diarrhea, leukopenia (reduction of white blood cells), sepsis and vomiting and there is evidence of a higher frequency of certain types of infections. E-mail this page to a friend or colleague! To print, use this version