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| |  FDA Approves CellCept (Mycophenolate Mofetil) To Help Prevent Rejection Of Liver Transplants NUTLEY, NJ -- August 9, 2000 -- Hoffmann-La Roche Inc. announced that it has received marketing clearance from the U.S. Food and Drug Administration (FDA) for expanded use of CellCept® (mycophenolate mofetil) for the prevention of organ rejection in patients undergoing liver transplantation. CellCept had been previously approved for use in kidney and heart transplantation. CellCept is to be used with cyclosporine and corticosteroids. The FDA based its decision on a double-blind, randomized 565 patient multicenter study to examine the effect of CellCept on acute rejection and survival in liver transplant patients comparing the use of MMF against azathioprine (AZA) in combination with cyclosporine and corticosteroids. The study, led by Dr. Russ Wiesner of Mayo Clinic, Rochester, MN, showed CellCept to be superior to AZA in preventing acute rejection six months post-transplant (statistically significant at the <0.05 level). Rate of death or retransplantation in comparison one year later was similar to AZA (14.7 percent vs. 14.6 percent respectively). "The study is affirmation, from a controlled multicenter study, of what numerous single-center studies have previously found," said Dr. Robert Gordon, Medical Director, Transplantation, Roche Laboratories. "It confirms that CellCept is a very effective anti-rejection tool in kidney, heart and now liver transplants." "There are more than 16,000 people on the waiting list for a liver transplant, and numbers are increasing rapidly," said Dr. Eddy Anglade, Medical Director, Transplantation, Roche Laboratories. "Having another drug in the liver transplant arsenal is important news for the transplant community." Patients enrolled in the study received 1 g bid CellCept intravenously for up to 14 days followed by MMF 1.5 g bid orally, or azathioprine 1-2 mg.kg.day intravenously followed by azathioprine 1-2 mg.kg.day in combination with cyclosporine and corticosteroids as maintenance immunosuppressive therapy. The principal side effects associated with CellCept have included diarrhea, a reduction in blood levels of white blood cells, sepsis, nausea and vomiting, and evidence of a higher frequency of certain types of infections. Adverse events reported in > 30 percent of cardiac transplant patients receiving either CellCept 3g/day or AZA 1.5 to 3mg/kg/day (in combination with cyclosporine and corticosteroids) were pain, fever, headache, asthenia, anemia, leukopenia, leukocytosis, hypertension, hypotension, peripheral edema, hypercholesteremia, hyperglycemia, creatinine and BUN increased, diarrhea, constipation, nausea, respiratory infection, dyspnea, insomnia. Increased hypokalemia, vomiting, and cough and lung disorder were also reported in more than 30 percent of patients receiving CellCept. The overall incidence of opportunistic infections was approximately 10 percent higher in cardiac transplant patients treated with CellCept than in those receiving azathioprine, but this difference was not associated with excess mortality due to infection/sepsis among patients treated with CellCept. The CellCept group had more herpes simplex and herpes zoster than the azathioprine group. Related Link: Hoffmann-La Roche.
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