Gilead Sciences Receives EU Approval for Breakthrough Twice-Yearly HIV PrEP Therapy Yeytuo (lenacapavir)

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(Source: Zhitong Finance)

SmartCom News APP learned that Gilead Sciences (GILD.US) announced today that the European Commission (EC) has approved its HIV-1 capsid inhibitor Yeytuo (lenacapavir) for marketing as a pre-exposure prophylaxis (PrEP) therapy to reduce the risk of HIV-1 infection due to sexual transmission in high-risk adults and adolescents (weighing at least 35 kg). According to the press release, Yeytuo is the first twice-yearly HIV PrEP therapy in the European Union (EU).

AIDS is an infectious disease caused by HIV infection. The development of modern antiviral drugs and the rise of "cocktail therapy" have enabled patients with HIV infection to control their condition over the long term and achieve a life expectancy comparable to that of healthy individuals. Recent studies have found that taking antiviral drugs before exposure can reduce the risk of HIV infection. This preventive treatment for HIV infection is called PrEP therapy.

The EU approval of lenacapavir was primarily based on the results of the Phase 3 PURPOSE 1 and PURPOSE 2 clinical trials. Lenacapavir is a "first-in-class" long-acting HIV capsid inhibitor that can interfere with the assembly and disassembly of the HIV capsid protein, acting at multiple stages of the viral life cycle.