Roche has received a fresh approval from regulators in the USA for its transplant drug Valcyte to be used by young children.

The US Food and Drug Administration has approved Valcyte (valganciclovir) for the prevention of cytomegalovirus disease in paediatric kidney and heart transplant patients (from 4 months to 16 years of age) who are at high risk of developing CMV disease. The agency has also given the green light to a new paediatric oral solution formulation which will allow easier administration to younger patients
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Roche quoted Richard Freeman of the Tufts Medical Center as saying that 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”. He added that dosing can be challenging “because children are not small adults” and the new oral formulation will help.

The Swiss major noted that over the past 21 years, more than 35,000 children aged 17 and younger have been transplant recipients in the USA. Before “preventative measures were taken to reduce the risk of infection”, Roche said, CMV among paediatric transplant patients was found in 26% of thoracic organ and 22% of kidney recipients.

Valcyte was previously indicated for the treatment of CMV retinitis in patients with AIDS, and for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk. First-half sales were up 7% to 274 million Swiss francs, about $260 million.