Gilead Sciences announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) and EU-Medicines for all (EU-M4all) application for lenacapavir, a twice-yearly injectable HIV prevention drug. The EMA granted accelerated assessment based on the potential public health impact of lenacapavir. This follows the FDA’s acceptance of similar applications under priority review.
This accelerated review by the EMA signifies a potential turning point in HIV prevention. A twice-yearly injection could drastically improve adherence compared to daily oral PrEP medications, potentially leading to a significant reduction in new HIV infections, particularly in underserved communities. The parallel EU-M4all application also demonstrates a commitment to equitable access by facilitating expedited review processes in low- and lower-middle-income countries.
The EMA’s validation is based on positive Phase 3 trial data. The PURPOSE 1 trial in cisgender women demonstrated 100% risk reduction in HIV infections with lenacapavir compared to background incidence rates. The PURPOSE 2 trial in cisgender men and gender-diverse people showed a 96% risk reduction. In both trials, lenacapavir was superior to daily oral Truvada and demonstrated a generally well-tolerated safety profile.
The EMA’s accelerated review, combined with the FDA’s priority review, suggests a high likelihood of regulatory approval in the near future. This could pave the way for a paradigm shift in HIV prevention strategies globally, offering a long-acting and potentially more convenient option for individuals and healthcare providers. The parallel review for low- and lower-middle-income countries reinforces a commitment to global health equity and underscores the potential for lenacapavir to significantly impact the HIV epidemic worldwide.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
