FDA approves the usage of Valcyte for preventing CMV disease in pediatric patients

Aug 31 2009

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Valcyte(R) (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.

"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," noted Richard Freeman, M.D., Vice Chair for Research, Department of Surgery, Professor of Surgery, Tufts Medical Center. "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."

CMV (herpesvirus) infects approximately 80 percent of the U.S. population depending on age. In the majority of cases the virus lies dormant in the body throughout life, but can be reactivated at times when the immune system is weakened (such as transplant patients and AIDS patients). In patients who have received an organ transplant, CMV infection usually develops during the first few months after transplantation, and may cause complications in the lungs, kidneys, nervous system, liver, and gastrointestinal tract. CMV can lead to the loss of the transplanted organ, and studies have shown that the virus has been correlated with an increased risk of death in post-transplant patients.

Over the past 21 years, more than 35,000 children ages 17 and younger have been transplant recipients in the U.S. Before preventative measures were taken to reduce the risk of infection, CMV among pediatric transplant patients was found in 26 percent of thoracic organ and 22 percent of kidney recipients.

New Pediatric Indication in Organ Transplant Patients

Valcyte, the leading anti-CMV agent, is now approved for the prevention of CMV disease in pediatric patients 4 months to 16 years of age who have undergone kidney or heart transplantation and who are at high risk for developing CMV disease. 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.

Source: http://www.roche.com