Gilead Submits Lenacapavir New Drug Application (NDA) to FDA (USA)

Gilead has submitted on 28 June 2021 a New Drug Application (NDA) to the U.S. Food and Drug Administration for lenacapavir, an investigational, long-acting agent in development for the treatment of HIV in people living with HIV who are heavily treatment-experienced. If approved, lenacapavir would be the first and the only HIV treatment option administered every six months.