The FDA has approved Valcyte (valganciclovir hydrochloride) for the prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant recipients (aged four months to 16 years) who are at high risk of developing the disease.
FDA also approved a new pediatric oral solution formulation for the drug that will enable easier administration to these patients.
In a press release issued by the drug’s maker, Roche Pharmaceuticals, Richard Freeman, MD, Professor of Surgery at Tufts Medical Center in Boston, where he is Vice Chair for Research in the Department of Surgery, observed: “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.”
The safety and efficacy of Valcyte has not been established in the prevention of CMV disease in pediatric solid organ transplant patients under four months of age or for the treatment of congenital CMV, according to Roche.