Gilead’s HIV-Prevention Drug Wins FDA Panel Backing

An FDA advisory committee backed Gilead Sciences’ Descovy for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative yet at risk.

• 16 members voted in favor of the drug to reduce the risk in men and transgendered women who have sex with men; 2 voted against it
• 10 participants voted that the drug did not benefit cisgender women; 8 voted in favor of the drug
• SVB Leerink analyst Geoffrey Porges (market perform, PT $76) wrote in an Aug. 5 note that the “benign AdCom” was likely to endorse broad use of the drug ...