Friday, May 11, 2012

FDA panel backs Gilead's four drugs-in-one HIV tablet

An HIV therapy from Gilead Sciences Inc. that combines four drugs, including a new booster, into one once-a-day pill won the backing of an FDA advisory panel Friday. The committee voted 13-1 to recommend that the Quad pill from Foster City-based Gilead (NASDAQ: GILD) be approved by the Food and Drug Administration. The FDA will decide by Aug. 27 whether to approve the Quad pill, but it is not bound to follow the panel's vote. The panel included a recommendation that patients undergo extra kidney tests, after FDA staff found a number of kidney-related side effects, including kidney failure, in HIV patients who took Quad in clinical trials.

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