Valcyte Supplemental Approval Extends Treatment Time

Genentech, Inc., a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) approved increasing the length of therapy with Valcyte (valganciclovir hydrochloride) in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease.

The supplemental approval is based on data that showed longer prophylactic treatment with Valcyte reduced the incidence of CMV disease in high-risk adult kidney transplant patients from 36.8 percent (for patients who received 100 days of treatment) to 16.8 percent (for patients who received treatment for 200 days) at one year after receiving a transplanted kidney (p<0.0001). The overall safety profile of Valcyte did not change with the extension of prophylaxis in high-risk kidney transplant patients.

“Among the different risks people face after a kidney transplant, CMV is one that may be prevented through prophylactic treatment with Valcyte,” said Investigator, Dr. Atul Humar, Director, Transplant Infectious Diseases and Associate Professor, Department of Medicine, University of Alberta, Canada. “Data now demonstrate that we may further reduce the risk of CMV infection by increasing the duration of preventative treatment from 100 to 200 days.”

CMV is a major cause of illness and disease during the first six months following transplantation1. It is estimated that 50-80 percent of all adults are infected with the CMV virus, which most often lies dormant in the body throughout life. The virus can be activated at times when the immune system is weakened such as after organ transplantation. CMV infection may cause complications in the lungs, kidneys, nervous system, liver, and gastrointestinal tract2.

“Despite advances in the management of CMV, studies have shown that more than a third of patients still develop CMV infection even after 100 days of prophylaxis,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer. “This approval provides important information for physicians treating high-risk adult patients during the critical period after kidney transplant.”

Date: August 10, 2010
Source: Genentech, Inc.