FDA approves extended use of Valcyte for kidney transplant patients

SOUTH SAN FRANCISCO, Calif. The Food and Drug Administration is allowing kidney transplant patients to use a drug for a related viral infection for a longer period of time.

Genentech, Swiss drug maker Roche’s U.S. division, announced Wednesday that the agency had approved extending the time during which patients can use Valcyte (valganciclovir hydrochloride). The drug is used in patients at high risk for cytomegalovirus disease, a major cause of illness and disease during the six months after a transplant is received.

“Despite advances in the management of CMV, studies have shown that more than a third of patients still develop CMV infection even after 100 days of prophylaxis,” Genentech EVP global development and chief medical officer Hal Barron said. “This approval provides important information for physicians treating high-risk adult patients during the critical period after kidney transplant.”

An estimated 50 to 80% of all adults carry the virus, which mostly lies dormant throughout life, according to the Centers for Disease Control and Prevention, though the virus can cause mononucleosis, similar to the more common Epstein-Barr virus.