Pharmaceutical Technology

Gilead’s lenacapavir moves closer to FDA approval for HIV PrEP use

The FDA has accepted Gilead’s new drug application with a decision expected by 19 June 2025.

Gilead is edging closer to an approval for its twice-yearly injectable human immunodeficiency virus-1 (HIV-1) capsid inhibitor, lenacapavir, as a pre-exposure prophylaxis (PrEP) option.

The US Food and Drug Administration (FDA) has accepted Gilead’s new drug application (NDA) for lenacapavir and set a prescription drug user fee act (PDUFA) target action date of 19 June 2025.

Lenacapavir is already approved under the name Sunlenca as an HIV treatment for patients resistant to other medication options. Gilead is a major player in the HIV and AIDS research space and currently markets several HIV treatments, including Biktarvy (bictegravir /emtricitabine/tenofovir alafenamide) and Descovy (emtricitabine/tenofovir). These drugs pulled in $15.5bn in sales for Gilead in 2024, as announced by the company earlier this month.

Gilead is also planning its broader access strategy for lenacapavir as PrEP. In the 18 February announcement, the company said it submitted a marketing authorisation application to the European Commission and an EU-Medicines for All (EU-M4all) application to the European Medicines Agency (EMA). The EU-M4all procedure is designed to support regulatory pathways in low- and lower-middle-income countries by allowing national authorities to use the EU opinion to accelerate their own review processes, potentially expediting access to lenacapavir for PrEP in these regions.

A twice-yearly injectable PrEP option like lenacapavir could offer significant advantages over the commonly used daily oral PrEP options, like Gilead’s Truvada (emtricitabine/tenofovir), particularly in terms of adherence and accessibility, said Linda-Gail Bekker, director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, in a previous announcement.

“While we know traditional HIV prevention options are highly effective when taken as prescribed, twice-yearly lenacapavir for PrEP could help address the stigma and discrimination some people may face when taking or storing oral PrEP pills, as well as potentially help increase PrEP adherence and persistence given its twice-yearly dosing schedule,” Bekker stated.

The FDA’s review is based on data from the Phase III PURPOSE 1 and PURPOSE 2 trials conducted by Gilead. PURPOSE 1 (NCT04994509) showed zero HIV infections in the lencapavir group, indicating a 100% risk reduction compared to background HIV incidence (bHIV) among cisgender women. PURPOSE-2 (NCT04925752) reported two HIV infections in the lenacapavir group, translating to a 96% risk reduction. The drug also demonstrated superior efficacy over Gilead’s daily oral PrEP option Truvada (emtricitabine/tenofovir).

Researchers have long spoken about ending the HIV/AIDS crisis. The World Health Organization (WHO) has a 2022–2030 global health sector strategy on HIV, which aims to reduce HIV infections from 1.5 million in 2020 to 335,000 by 2030, and deaths from 680,000 in 2020 to under 240,000 in 2030.

In May 2024, a group of public figures, scientists, medical professionals, and celebrities called on Gilead to improve access to HIV drugs in low- and middle-income countries (LMICs). In October 2024, Gilead Sciences announced that it had signed voluntary licensing agreements with six generic pharmaceutical manufacturers to expand access to lenacapavir in 120 resource-limited and high-incidence countries.