The Antiviral Drugs Advisory Committee of the FDA has recommended the approval of Gilead's Quad to treat HIV-1 infection in treatment-naive adults.
The Quad is a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate.
Gilead HIV therapeutics and development operations senior vice president Andrew Cheng said, "With new government guidelines recommending that people diagnosed with HIV begin treatment early, it is important that we continue to simplify and improve HIV therapy."
The recommendations of the committee will be considered by FDA as the agency completes its review of NDA of the Quad.
The two pivotal Phase 3 studies in which Quad met its primary objective of non-inferiority as compared to Atripla and to a regimen containing ritonavir-boosted atazanavir plus Truvada will support the Quad NDA.
Applications for marketing approval of the Quad are pending in Australia, Canada and the European Union, the company said.
