Gilead’s Lenacapavir PrEP gets FDA Review

USA—Gilead Sciences, a leading American pharmaceutical company, is advancing towards regulatory approval for its twice-yearly injectable HIV-1 treatment, lenacapavir, as a pre-exposure prophylaxis (PrEP) option.

The U.S. Food and Drug Administration (FDA) has accepted the new drug application and set a target decision date of June 19, 2025.

This marks an important milestone in expanding HIV prevention methods, as lenacapavir is designed to be administered only twice a year, offering a significant alternative to daily oral PrEP medications.

Previously, lenacapavir was approved under the brand name Sunlenca for treating HIV in patients who have developed resistance to other therapies.

Gilead has already built a strong reputation in HIV and AIDS research, with a portfolio that includes treatments such as Biktarvy and Descovy.

These medications contributed to a robust sales figure of US$15.5 billion in 2024, highlighting Gilead’s prominence in the field.

In addition to its work in the United States, Gilead is actively pursuing broader access to lenacapavir internationally.

The company recently submitted a marketing authorization application to the European Commission, along with an EU-Medicines for All (EU-M4all) application to the European Medicines Agency.

The EU-M4all process is particularly noteworthy because it aims to streamline regulatory approval in low- and lower-middle-income countries.

 This could potentially expedite the availability of lenacapavir as a PrEP option in regions where HIV incidence remains high.

Experts have highlighted the potential benefits of this new approach. Linda-Gail Bekker, director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, noted that a twice-yearly injectable could significantly improve adherence to PrEP regimens.

She explained that, while traditional daily oral treatments are highly effective when used consistently, the injectable option may reduce the stigma and logistical challenges associated with daily pill routines.

Furthermore, its less frequent dosing schedule could improve overall accessibility and encourage long-term persistence in HIV prevention.

The FDA’s review is based on promising data from two Phase III clinical trials, PURPOSE 1 and PURPOSE 2.

PURPOSE 1, which focused on cisgender women, reported zero HIV infections in the lenacapavir group, indicating a 100% risk reduction compared to the background incidence rate.

Meanwhile, PURPOSE 2 showed a 96% risk reduction, with only two HIV infections occurring in the lenacapavir group.

These results suggest that lenacapavir not only matches but may even surpass the effectiveness of existing daily oral PrEP options like Truvada.

Moreover, the global fight against HIV/AIDS continues to gain momentum. The World Health Organization has set ambitious targets under its 2022–2030 global health strategy, aiming to reduce new HIV infections and related deaths drastically.

 In line with these goals, public figures, scientists, and medical professionals have urged companies like Gilead to improve access to HIV drugs in low- and middle-income countries.

Reflecting this commitment, Gilead announced in October 2024 that it had entered voluntary licensing agreements with six generic manufacturers to expand access to lenacapavir in 120 resource-limited, high-incidence countries.

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