Roche's oral anti-CMV prodrug approved

Roche has been granted approval by the US Food and Drug Administrationfor its oral prescription drug Valcyte (valganciclovir), to treat AIDS-related cytomegalovirus retinitis, an opportunistic infection which affects 10%-25% of people in the late stages of AIDS. Clinical studies show Valcyte, a prodrug of Roche's existing intravenous anti-CMV treatment, Cytovene IV (ganciclovir), had comparable efficacy for induction therapy of CMV compared to its parent molecule. Studies of Valcyte for CMV prevention in solid organ transplantation recipients are underway, and applications for marketing authorization in this indication are anticipated in the second quarter of 2002.