Press room ... 2001 archive

Valganciclovir Recommended for Approval

March 9, 2001

San Francisco—The Antiviral Drugs Advisory Committee to the Food and Drug Administration (FDA) recommended that valganciclovir be approved for treating active CMV retinitis and maintenance therapy (to prevent relapse of CMV). Valganciclovir is an improved oral formulation of ganciclovir. Clinical studies show that valganciclovir is as effective as the intravenous (injection into the vein) form of the drug, which is commonly used to treat CMV disease.

The dose used to treat CMV retinitis in the study was 900mg twice a day for the first 21 days and then 900mg once a day for the next seven days. However, maintenance therapy usually requires for the drug to be given lifelong.

Valganciclovir is expected to be available in pharmacies in May 2001. In the meantime, an expanded access program is open for early access to the drug. Call Project Inform's Hotline toll-free at 1-800-822-7422 for a list of sites participating in this program.