Nephrology-enhanced 'Quad' squad of FDA advisors backs Gilead's HIV combo
This article was originally published in Scrip
Executive Summary
As expected, on May 11 the USFDA's Antiviral Drugs Advisory committee gave a strong endorsement to Gilead Sciences four-drug pill for treatment-naive HIV patients. With 13 of the 14 voting members of the panel agreeing that clinical trial results support approval of the combination, the agency is likely to back marketing of the combo by its August 27 deadline to act on the new drug application.