August 11, 2010
Longer use of Valcyte for renal transplant patients approvedThe FDA has approved a longer duration of therapy with Valcyte (valganciclovir, from Genentech) in adult renal transplant patients at high risk for cytomegalovirus (CMV) disease. This supplemental approval is based on data that showed that longer prophylactic treatment with Valcyte for 200 days reduced the incidence of CMV disease in high-risk adult kidney transplant patients from 36.8% (100 days of therapy) to 16.8% (200 days of therapy) at one year after receiving a transplanted kidney (p<0.0001).
Valcyte is indicated for the treatment of AIDS-related CMV retinitis; prevention of CMV disease in kidney, heart, or kidney-pancreas transplant adult patients at high risk; and prevention of CMV disease in kidney and heart transplant pediatric patients (4 months to 16 years old) at high risk.
For more information call (800) 821-8590 or visit www.valcyte.com.