GILEAD VISTIDE DELAYS CMV RETINITIS PROGRESSION 57 DAYS; ADVISORY CMTE. RECOMMENDS FIRST-LINE USE; HYDRATION, PROBENECID CONCOMITANT USE REQUIRED
Executive Summary
Gilead's nucleotide analog Vistide (cidofovir I.V.) delayed detection of progression of AIDS-related cytomegalovirus retinitis by 57 days in patients who had received no prior therapy for the disease, FDA statistician Alan Muhly, PhD, told a March 15 joint meeting of FDA's Antiviral Drugs and Ophthalmic Drugs Advisory Committee Subcommittee. Gilead Sciences submitted NDA 20-638 for Vistide, its lead product, in October.