FDA approves longer Valcyte therapy for CMV disease in adult kidney transplant patients

FDA approved increasing the length of therapy with Valcyte (valganciclovir hydrochloride) in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease, according to Genentech Inc. on Aug. 10.

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% (for patients who received 100 days of treatment) to 16.8% (for patients who received treatment for 200 days) at 1 year after receiving a transplanted kidney (P<.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 Atul Humar, MD, an investigator and director of transplant infectious diseases and associate professor in the Department of Medicine at the 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 6 months following transplantation. It is estimated that 50% to 80% 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 tract.

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