FDA advisory panel vote 13:1 for approval of Quad

On 11 May 2012, the US FDA Antiviral Drugs Advisory Committee held an open meeting to decide on recommendations for approval for the 4-in-1, fixed dose combination (FDC) Quad (elvitegravir/cobicistat/tneofovir/FTC), manufactured by Gilead.

The panel voted 13:1 in favour of recommending approval. The vote against came from a nephrologist and was based on the current availability of existing options for which there is more established renal safety data.

The FDA nearly always follows panel recommendations though this is not mandatory.

As part of this process, the FDA publish a briefing document prior to each advisory panel meeting, available in PDF format online, which compiles a review of the data.

Links and further information:

FDA briefing document: 200-page new drug application (PDF)

Gilead PR. FDA committee supports approval of Gilead’s once-daily Quad single tablet regimen for HIV (11 May 2012)

Links to other websites are current at date of posting but not maintained.