Gilead pharmaceutical company announced today (Tuesday, Feb. 18) that the U.S. Food and Drug Administration has accepted the company’s “new drug applications” for lencapavir, a twice-yearly injectable HIV-1 capsid inhibitor as a PrEP medication.
Dietmar Berger, MD, PhD, chief medical officer for Gilead Sciences, said in a written statement that this approval brings the company “one step closer to introducing the first-ever twice-yearly HIV prevention choice that could, if approved, help transform the landscape for individuals who need or want additional prevention options that better fit into their lives.”
Berger continued, “We’re excited about the potential of lenacapavir to make a real difference in HIV prevention in the U.S. and around the world, supporting the broader goal of ending the HIV epidemic for everyone, everywhere.”
According to a press release from Gilead, “Acceptance of the NDAs follows receipt of Breakthrough Therapy Designation for lenacapavir for PrEP granted by the FDA in October 2024.” The FDA will now review the applications “under priority review and has assigned a Prescription Drug User Fee Act target action date of June 19, 2025,” the press release notes.
The press release also stresses that “use of lenacapavir for the prevention of HIV is investigational and is not approved anywhere globally. The safety and efficacy of this use has not been established” by the FDA.