FDA approves Gilead NDA for Quad HIV Regimen

The Quad contains four Gilead compounds in a complete once-daily, single-tablet regimen that include elvitegravir; cobicistat, a boosting agent that enables elvitegravir once-daily dosing; and Truvada(R) (emtricitabine/tenofovir disoproxil fumarate).

Elvitegravir is an integrase inhibitor which interferes with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells.

Cobicistat is Gilead’s proprietary potent mechanism-based inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body.

Gilead submitted the Quad NDA on 27 October 2011 and the FDA has set a target review date for the Quad under the Prescription Drug User Fee Act (PDUFA) of 27 August 2012.