Gilead Sciences has submitted marketing authorization applications to the European Medicines Agency (EMA) for lenacapavir HIV prevention, a twice-yearly injectable pre-exposure prophylaxis (PrEP) for HIV prevention. This marks a critical step in expanding prevention options.

Regulatory Submissions and Fast-Track Review for Lenacapavir

Gilead filed two applications:

• A Marketing Authorization Application (MAA) to the European Commission for lenacapavir as PrEP.
• An EU-Medicines for All (EU-M4all) application, enabling faster approval in low- and lower-middle-income countries by leveraging the EU’s assessment.

The EMA will conduct a parallel Accelerated Assessment, recognizing lenacapavir´s potential public health impact and therapeutic innovation.

Clinical Evidence and Safety of Lenacapavir

The submissions rely on data from Phase 3 PURPOSE 1 and PURPOSE 2 trials:

• PURPOSE 1: Zero HIV infections among cisgender women in the lenacapavir HIV prevention group, showing 100% risk reduction compared to background HIV incidence (bHIV).
• PURPOSE 2: Lenacapavir HIV prevention achieved a 96% risk reduction among cisgender men and gender-diverse individuals, outperforming daily oral Truvada (TDF/FTC). Only two infections occurred among 2,180 participants on lenacapavir.

Both trials confirmed lenacapavir favorable safety profile, with no significant or new safety concerns reported.

U.S. Regulatory Status and Previous Approvals

Gilead also submitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) in December 2024 for PrEP. However, lenacapavir remains investigational for HIV prevention and is not yet globally approved.

Lenacapavir, marketed as Sunlenca, already has FDA approval for a different use. In 2023, the FDA approved it for adults with multi-drug resistant HIV-1, in combination with other antiretrovirals.

Expanding Global Access to Lenacapavir HIV Prevention

Gilead aims to accelerate lenacapavir’s regulatory approvals and ensure rapid availability in high-incidence regions. Its twice-yearly dosing could improve adherence compared to daily oral PrEP, offering a promising new tool in HIV prevention.