Gilead (GILD.US) has submitted a new indication for its long-acting HIV therapy, which is administered twice a year, resulting in a reduction of HIV infection risk by over 96%.

On February 18, Gilead (GILD.US) announced that the FDA has accepted its new drug application (NDA) for lenacapavir for pre-exposure prophylaxis (PrEP) of HIV, with a PDUFA target action date of June 19, 2025. Lenacapavir is a groundbreaking HIV-1 capsid inhibitor that offers convenient administration with a single injection every six months. Dr. Dietmar Berger, Gilead's chief medical officer, expressed: "We are one step closer to launching the first HIV prevention regimen that can be administered every six months. If approved, lenacapavir will help transform the lives of those who need or want more prevention options. We are thrilled about the potential positive impact lenacapavir could have on HIV prevention in the United States and globally, which will support our goal of ending the HIV epidemic for everyone, everywhere."