Gilead Sciences, Inc. : FDA Panel Backs Gilead's HIV 'Quad' Medicine
05/11/2012| 03:06pm US/Eastern
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By Jennifer Corbett Dooren
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A federal advisory panel Friday backed an experimental Gilead Sciences Inc. (GILD) HIV medicine known as the Quad.
The company is seeking approval from the Food and Drug Administration to market the product, which combines four active ingredients into one pill, meant to be taken once daily.
The medicine was reviewed on Friday by the agency's antiviral drugs advisory panel, which is made up of non-FDA medical experts. The panel voted 13 to 1 on a question that asked if the submitted clinical data supported approval of the drug. The panel vote amounts to a recommendation that the FDA approve the drug. The agency usually follows panel recommendations but isn't required to. The FDA is expected to make a decision by the end of August.
Quad is a combination of four active ingredients in one pill. It combines Gilead's double-drug Truvada, the drug elvitegravir and an agent that boosts blood levels of certain HIV drugs, cobicistat.
Gilead is hoping that the one-pill, once-daily Quad regimen will provide more convenience to HIV patients, many of whom now take multiple pills for treatment. Some analysts think it could become a blockbuster seller.
-By Jennifer Corbett Dooren; Dow Jones Newswires, 202-862-9294; jennifer.corbett@dowjones.com
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