Gilead Sciences announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on lenacapavir, the company's injectable HIV-1 capsid inhibitor, under an accelerated assessment procedure, recommending it as a pre-exposure prophylaxis (PrEP) drug.For reducing the risk of acquiring HIV-1 through sexual activity in adults and adolescents at higher risk of HIV-1 infection. The final decision of the European Commission (EC) is expected to be announced later this year.According to the press release, if approved, lenacapavir will become 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.

Truvada, an antiviral drug developed by Gilead Sciences, has been FDA-approved for PrEP for over a decade. Although taking Truvada daily can almost 100% prevent HIV infection, many people struggle to take it daily due to factors such as the cost of the drug and the stigma associated with taking HIV-related medications. As a result, the real-world effectiveness of oral PrEP is far lower than its theoretical potential. Therefore, there is a significant need to develop a long-acting HIV PrEP therapy that can improve medication adherence.

This recommendation for lenacapavir by the CHMP is primarily based on the results of the Phase 3 PURPOSE 1 and PURPOSE 2 clinical trial data. In the PURPOSE 1 study, the main analysis data shows,None of the 2,134 participants in the group receiving subcutaneous injections of lenacapavir twice a year contracted HIV, achieving a 100% prevention effect against HIV infection., and is superior to the daily oral Truvada treatment group in preventing HIV infection. In the PURPOSE 2 study,In the lenacapavir group of 2,179 participants, there were only two cases of HIV infection, indicating that 99.9% of the participants in this group remained free of HIV infection., and superior to the daily oral Truvada treatment group in preventing HIV infection. Both studies showed that lenacapavir was more effective than the background HIV incidence rate (bHIV) in preventing HIV infection, with overall good tolerability and no significant or new safety issues identified. The data from both studies have been published in The New England Journal of Medicine.

Lenacapavir is a "first-in-class" long-acting HIV capsid inhibitor that can interfere with the assembly and disassembly of HIV capsid proteins, acting at multiple stages of the viral life cycle.It has been granted Breakthrough Therapy Designation by the U.S. FDA for pre-exposure prophylaxis of HIV infection and received FDA approval in June this year.Approved for MarketingIn 2024, the journal *Science* also rated lenacapavir asBreakthrough of the Year, indicating that this "first-in-class" drug has brought new hope for the long-acting treatment and prevention of AIDS.

▲Lenacapavir (Image Source: Reference [2])

References:

[1] Gilead Receives Positive CHMP Opinions Under Accelerated Review From European Medicines Agency for Twice-Yearly Lenacapavir for HIV Prevention. Retrieved July 25, 2025 from https://www.businesswire.com/news/home/20250724024903/en/Gilead-Receives-Positive-CHMP-Opinions-Under-Accelerated-Review-From-European-Medicines-Agency-for-Twice-Yearly-Lenacapavir-for-HIV-Prevention

[2]  Yeztugo® (Lenacapavir) Is Now the First and Only FDA-Approved HIV  Prevention Option Offering 6 Months of Protection. Retrieved June 18,  2025 from  https://www.businesswire.com/news/home/20250520465880/en/Yeztugo-Lenacapavir-Is-Now-the-First-and-Only-FDA-Approved-HIV-Prevention-Option-Offering-6-Months-of-Protection

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