valcyte是什么时候上市的？

The U.S. Food and Drug Administration (FDA) has approved increased use in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease. The supplemental approval is based on data that longer-term prophylaxis with valcyte reduced the incidence of CMV disease in high-risk adult kidney transplant patients from 36.8% (for patients who received 100 days of treatment) to 16.8% (for patients who received 200 days of treatment at one year after receiving a kidney) (p < 0.0001). 1.2 The overall safety profile of valcyte did not change when prophylaxis was extended in high-risk adult kidney transplant patients.

The antiviral effects of valcyte have been demonstrated clinically in the treatment of AIDS patients with newly diagnosed retinitis (clinical study WV15376). After 4 weeks of treatment with valcyte, the detection rate of CMV virus decreased from 46% (32/69) to 7% (4/55). Clinical studies of valcyte in AIDS patients infected with CMV retinitis have shown that valcyte and intravenous ganciclovir are equally effective in the induction treatment of CMV retinitis.

In the study, patients with newly diagnosed CMV retinitis were randomly assigned to valcyte or intravenous ganciclovir for induction therapy. The proportion of patients with progression of CMV retinitis at week 4 was the same in both groups. After induction therapy, both groups of patients in the study continued to receive maintenance therapy with 900 mg of valcyte per day. The mean (median) time from randomization to progression of CMV retinitis was 226 (160) days and 219 (125) days in patients who received valcyte or intravenous ganciclovir induction therapy followed by valcyte maintenance therapy, respectively.

In May 2001, the US FDA approved the market. Valcyte is clinically used to treat acute retinitis caused by CMV infection in patients with acquired immunodeficiency syndrome. In May 2003, its indications were expanded. Valcyte is used to prevent and treat secondary CMV infection in organ transplant recipients. On August 11, 2010, Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) approved the drug for the treatment of adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease. Patients can purchase through formal channels.