EU Regulator Approves Lenacapavir, a Long-Acting Injectable HIV Prevention Drug

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The European Medicines Agency (EMA) has issued a positive recommendation for lenacapavir, a twice-yearly injectable drug developed by Gilead Sciences, for pre-exposure prophylaxis (PrEP) against HIV-1 infection. The approval marks a major advancement in HIV prevention, offering the longest-lasting protection currently available.

Lenacapavir, marketed as Yeytuo in Europe, is already approved for HIV treatment and has demonstrated near-total efficacy in preventing transmission in clinical trials involving both men and women. The drug works by inhibiting the HIV-1 capsid function, effectively blocking viral replication.

The EMA’s recommendation follows accelerated review and applies to adults and adolescents at increased risk of HIV, weighing at least 35 kg. The treatment regimen includes an initial dose of oral tablets followed by injections every six months.

While hailed as a public health breakthrough, concerns remain over global accessibility. Gilead has committed to licensing generic versions of lenacapavir in 120 low-income countries, primarily in Africa, Southeast Asia, and the Caribbean, but critics note that Latin America has been largely excluded from this plan.

The European Commission is expected to formally authorize the drug later this year, extending its availability across all 27 EU member states, as well as Norway, Iceland, and Liechtenstein.

You can read more from the European Medicines Agency’s official summary and U.S. News Health Report.

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