Gilead Sciences, Inc., announced in late November that it has submitted a New Drug Application to the U.S. Food and Drug Administration. The company seeks marketing approval of the single-tablet regimen of Truvada combined with Tibotec Pharmaceuticals’ investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults. If approved, this would be the second product that contains a complete HIV treatment regimen in a single once-daily tablet.
“Combination antiretroviral therapy has dramatically advanced the field of HIV medicine, but the need remains for new single-tablet regimens that are effective, safe, and well tolerated,” said John C. Martin, PhD, chairman and chief executive officer of Gilead Sciences. “Gilead is committed to helping advance HIV treatment by pursuing both scientific research and innovative partnerships that will deliver more options to the healthcare community. We are pleased to work with Tibotec to bring this potentially important new therapy to people living with HIV.”
Subject to regulatory approval, Gilead will assume the lead role in the manufacturing, registration, distribution, and commercialization of the single-tablet regimen worldwide, excluding the developing world and Japan.
Truvada/TMC278 is an investigational product and its safety and efficacy have not yet been established. gilead.com. —Nancy Ford