Panel backs Gilead Sciences' Truvada for HIV-1 prophylaxis (GILD)

Gilead Sciences, Inc. (NASDAQ:GILD) is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and experimental drug candidate, Gilead seeks to improve the care of patients suffering from life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, hepatitis, serious respiratory, cardiovascular, and metabolic conditions, cancer and inflammation. Their portfolio of 14 marketed products includes a number of category firsts, including the only complete treatment regimens for HIV infection available in a once-daily single pill – Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), approved in 2006, and Complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), approved in 2011.

BioCentury.com reports that the FDA's Antiviral Drugs Advisory Committee has concluded that "the benefit-risk profile for Truvada emtricitabine/tenofovir...supports the drug's use as pre-exposure prophylaxis (PrEP) to reduce risk of HIV-1 infection in uninfected adults." 

Committee members voted 19-3 "in favor of recommending approval of the drug for high-risk men who have sex with men and 19-2, with one abstention, in favor of recommending approval in serodiscordant heterosexual couples. For other individuals at risk of acquiring HIV through sexual activity, the panel voted 12-8, with two abstentions, in favor of Truvada as PrEP."

According to the article,

"Panel members echoed the concerns of FDA briefing documents about inadequate adherence and the risk of resistance development. The panel recommended HIV testing at baseline and every few months thereafter should be part of Gilead's proposed REMS. 

An sNDA for Truvada is under Priority Review with a June 15 PDUFA date. The fixed-dose combination of the nucleoside analog reverse transcriptase inhibitors (NRTI) emtricitabine and tenofovir is approved to treat HIV infection. The votes occurred after market close. Gilead was up $0.61 to $51.25 on Thursday."

Read more at BioCentury.com.