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Gilead's Quad combination HIV pill recommended for approval by FDA advisers

Friday, May 11 2012 | Comments
Evidence Grade 0 What's This?
An advisory panel of the Food and Drug Administration voted in favor of approving Gilead Sciences Inc.'s once-daily combination tablet referred to as the Quad, which contains Gilead's Truvada (emtricitabine/tenofovir disoproxil fumarate) and the firm's investigational compounds elvitegravir and cobicistat, for the treatment of HIV-1 in treatment-naive adults. 

In a 13-1 vote, the FDA's Antiviral Drugs Advisory Committee recommended that the agency approve the combination tablet.

The FDA has set a target review date of Aug. 27 for the Quad New Drug Application (NDA). If approved, the Quad would be the only once-daily, single-tablet regimen containing an integrase inhibitor, Gilead noted.

The Quad NDA was based on 48-week data from two pivotal Phase III trials in which the Quad regimen achieved the main objective of noninferiority. The Quad tablet was compared with Gilead and Bristol-Myers Squibb Co. (BMS)'s Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) in one of the studies and was compared with a regimen containing Abbott's Norvir (ritonavir), BMS' Reyataz (atazanavir sulfate) and Truvada in the other study.

The Quad was well-tolerated in both studies, and most adverse events were mild to moderate.

Gilead also used chemistry, manufacturing and controls information on the individual components of the Quad tablet and the co-formulated single-tablet regimen to support the NDA.

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