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| |  Oral Cytovene for Prevention of CMV Disease Cleared By FDA NUTLEY, N.J., Dec. 3, 1996 -- Hoffmann-La Roche announced today that the company has received clearance from the Food and Drug Administration (FDA) to market oral ganciclovir (Cytovene(R) capsules) for the prevention of cytomegalovirus (CMV), a potentially life-threatening infection, in recipients of solid organ transplants. The FDA decision is based on data which demonstrate that oral Cytovene(R) given as prophylaxis reduced the overall incidence of CMV disease in liver transplant recipients by 78 percent. More than 20,000 people received solid organ transplants (heart, lung, pancreas, kidney, liver, etc.) in the U.S. in 1995. CMV disease occurs in approximately 15-30 percent of all solid organ transplant recipients -- primarily in the first three months post-transplantation when immunosuppression is most intense -- and is a frequent cause of morbidity. Prior to today's clearance of oral Cytovene, intravenous ganciclovir (Cytovene(R)-I.V.) was the only medication indicated as preventive therapy for CMV disease in solid organ transplant recipients. "The availability of oral Cytovene provides the transplant community with an effective and convenient option to prevent CMV disease in at-risk patients who receive solid organ transplants," said Mark Pescovitz, M.D., clinical investigator and transplant surgeon from the Indiana University Medical Center. "The prevention of CMV is a critical step in helping patients achieve a full recovery after transplantation." Transplant Recipients and CMV Cytomegalovirus, a member of the herpes family of viruses, infects approximately 50 percent of the U.S. adult population. In individuals with healthy immune systems, the virus remains in the body in a dormant state. However, among individuals with compromised immune systems, such as organ transplant recipients and people with AIDS, the virus can cause life- threatening and/or sight-threatening illness. CMV in transplant recipients can cause a debilitating CMV syndrome (fever, malaise), and life-threatening invasive tissue disease (including hepatitis and pneumonia), and increased immunosuppression with resulting secondary infections. "We're committed to meeting the treatment needs of the transplant community," said Stephen Sudovar, Senior Vice President of Pharmaceuticals, Hoffmann-La Roche. "Oral Cytovene -- our second transplant therapeutic -- is just one example of that commitment." Study Methodology and Results Oral Cytovene received marketing clearance based on the results of GAN 040, a multinational, randomized, double-blind study comprising 304 orthotopic liver transplant (OLT) recipients randomized (1:1) to receive oral ganciclovir (1000 mg three times daily) or matching placebo, for up to 14 weeks following transplantation. The six-month incidence of CMV disease was 18.9 percent in the placebo group compared to 4.8 percent in the oral Cytovene group. Of the oral Cytovene patients who developed CMV disease, only one (0.7 percent) developed invasive tissue disease, the most severe type of CMV disease, versus 8.4 percent of placebo patients. Oral Cytovene helped prevent CMV disease even in those recipients at highest risk for CMV disease -- those who were sero-negative for CMV at the time of their transplant and received a CMV sero-positive organ. The six- month incidence of CMV disease in this group was 44 percent in placebo patients versus 14.8 percent in oral ganciclovir patients. Patients who received the most intense immunosuppression also benefited from prophylaxis with oral Cytovene. Of those patients receiving anti-lymphocyte antibodies either for prevention of graft rejection or for treatment of refractory rejection, the incidence of CMV disease was 33 percent in the placebo group versus 4.6 percent in the ganciclovir group. The six month incidence of herpes simplex was reduced from 23.5 percent in the placebo arm to 3.5 percent in those receiving oral ganciclovir prophylaxis. The most common adverse events in this study were infection, fever and headache. These events occurred with similar frequency in the ganciclovir-treated and placebo groups. About Cytovene Cytovene-I.V. is indicated only for the prevention of CMV disease in transplant recipients at risk for CMV disease and for the treatment of CMV retinitis in immunocompromised patients, including people with AIDS. Cytovene capsules are indicated only for the prevention of CMV disease in HIV-infected individuals who are at risk of developing CMV disease, and as an alternative to the I.V. formulation for maintenance treatment of CMV retinitis in people with impaired immune systems whose CMV retinitis is stable following appropriate I.V. therapy and only in those for whom the risk of more rapid disease progression is balanced by the benefit associated with avoiding daily I.V. infusions. The clinical toxicity of Cytovene-I.V. and Cytovene capsules includes granulocytopenia, anemia and thrombocytopenia. In animal studies, ganciclovir was carcinogenic, teratogenic and caused spermatogenesis. About Hoffmann-La Roche Roche Bioscience, a member of the Roche Group located in Palo Alto, California, developed both the I.V. and oral formulations of Cytovene. Hoffmann-La Roche Inc. currently markets both formulations. Hoffmann-La Roche Inc. and Roche Bioscience are research-based health care companies and are members of the Roche Group, which is headquartered in Basel, Switzerland. Roche is a leading international health care company dedicated to the research, development and delivery of diagnostic tests, treatments and services for people infected with life-threatening diseases.
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