FDA Approves Valcyte to Prevent Cytomegalovirus (CMV) Disease in Pediatric Patients Who Receive Heart or Kidney Transplants

Roche announced today that the FDAhas approved Valcyte (valganciclovir hydrochloride) for the prevention ofcytomegalovirus (CMV) disease in pediatric kidney and heart transplantpatients (4 months to 16 years of age) at high risk of developing CMV disease.The FDA also approved a new pediatric oral solution formulation for Valcyte,which will allow easier administration to pediatric patients 4 months to 16years of age. “Children receiving organ transplants are especially vulnerable toinfection because of their reduced immunity, and the invasive procedure of atransplant can put them at higher risk of contracting CMV infection,” notedRichard Freeman, M.D., Vice Chair for Research, Department of Surgery,Professor of Surgery, Tufts Medical Center. “Prevention and medication dosingcan be challenging because children are not small adults. The new oralformulation and information about how to administer the medicine will helpdoctors treat their pediatric transplant patients.” CMV (herpesvirus) infects approximately 80 percent of the U.S. populationdepending on age. In the majority of cases the virus lies dormant in the bodythroughout life, but can be reactivated at times when the immune system isweakened (such as transplant patients and AIDS patients). In patients whohave received an organ transplant, CMV infection usually develops during thefirst few months after transplantation, and may cause complications in thelungs, kidneys, nervous system, liver, and gastrointestinal tract. CMV canlead to the loss of the transplanted organ, and studies have shown that thevirus has been correlated with an increased risk of death in post-transplantpatients. Over the past 21 years, more than 35,000 children ages 17 and younger havebeen transplant recipients in the U.S. Before preventative measures weretaken to reduce the risk of infection, CMV among pediatric transplant patientswas found in 26 percent of thoracic organ and 22 percent of kidney recipients.