Roche has announced that the FDA has approved Valcyte (valganciclovir hydrochloride) for the prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients (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 16 years of age.
Richard Freeman, vice chair for research at department of surgery and professor of surgery at Tufts Medical Center, said: Children receiving organ transplants are especially vulnerable to infection because of their reduced immunity, and the invasive procedure of a transplant can put them at higher risk of contracting CMV infection. Prevention and medication dosing can be challenging because children are not small adults. The new oral formulation and information about how to administer the medicine will help doctors treat their pediatric transplant patients.
Valcyte tablets are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Valcyte is indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.
The safety and efficacy of Valcyte has not been established in the prevention of CMV disease in pediatric solid organ transplant patients under 4 months of age or for the treatment of congenital CMV.