Valcyte Approved for Cytomegalovirus in Children
The U.S. Food and Drug Administration has approved Valcyte (valganciclovir hydrochloride) to prevent cytomegalovirus (CMV) disease in children 4 months to 16 years who are undergoing kidney or heart transplant, Swiss drug maker Roche said Monday.
CMV disease is a common infection among people who have had an organ transplant. Such patients may be infected with CMV before their surgeries, or be receiving organs that are infected, Roche said in a news release. Children are at increased risk of CMV infection and serious complications when their immune systems are suppressed to prevent rejection of donor organs.
CMV infects about 80 percent of the U.S. population, the company said, and in most cases lies dormant in the body. But when the immune system is weakened, CMV complications could affect the lungs, kidneys, nervous system, liver and gastrointestinal tract -- potentially leading to serious illness or death.
As part of the approval, the FDA sanctioned a new oral liquid form of the drug to allow for easier use in children, Roche said.
The drug has not been evaluated in transplant patients under 4 months of age, the company said.
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