Gilead's Lenacapavir Nears FDA Approval for HIV PrEP

Gilead Sciences is making strides toward gaining approval for its novel HIV-1 capsid inhibitor, lenacapavir, to be used as a pre-exposure prophylaxis (PrEP). This injectable treatment, administered twice yearly, is currently progressing through the approval process, with the US Food and Drug Administration (FDA) having accepted Gilead's new drug application. The FDA has set a target date of June 19, 2025, for their decision on this application.

Previously approved under the name Sunlenca for HIV treatment in patients resistant to other drugs, lenacapavir could become the first option of its kind, providing significant advantages over existing daily oral PrEP solutions, such as Gilead's Truvada. Lenacapavir's twice-yearly regimen could enhance adherence and accessibility, addressing challenges associated with daily medication, according to Linda-Gail Bekker, director of the Desmond Tutu HIV Center in South Africa.

Beyond the United States, Gilead is actively pursuing regulatory approvals in Europe. They have submitted a marketing authorization to the European Commission and an EU-Medicines for All (EU-M4all) application to the European Medicines Agency (EMA). The EU-M4all initiative assists in expediting drug approvals in low- and lower-middle-income countries, potentially accelerating lenacapavir's availability in these regions.

Clinical trials, namely the Phase III PURPOSE 1 and PURPOSE 2 studies, underpin the FDA's review. These trials demonstrated promising results: PURPOSE 1 achieved a 100% risk reduction in HIV infections among cisgender women, while PURPOSE 2 showed a 96% risk reduction in HIV infections, highlighting superior efficacy compared to daily oral PrEP options like Truvada.

The development of lenacapavir is timely, aligning with global efforts to combat the HIV/AIDS epidemic. The World Health Organization's strategy from 2022 to 2030 aims to reduce new HIV infections significantly, with targets to decrease infections from 1.5 million in 2020 to 335,000 by the end of the decade and deaths from 680,000 in 2020 to under 240,000 by 2030.

Public pressure has also played a role in Gilead’s actions. In May 2024, calls from various public figures and professionals urged the company to enhance the accessibility of HIV medications in resource-limited countries. Responding to these demands, in October 2024, Gilead announced agreements with six generic drug manufacturers to increase lenacapavir's availability in 120 countries with high HIV incidence and limited resources.

Lenacapavir represents a potential milestone in HIV prevention, offering hope for improved management of the epidemic, particularly in areas where existing prevention methods face challenges. If approved, its introduction could mark a significant advancement in the global fight against HIV/AIDS, providing an innovative option that could reshape preventative strategies across diverse populations.